Cost-effective, portable, patient-dedicated three-dimensional automated breast ultrasound for point-of-care breast cancer screening.

Breast cancer screening has substantially reduced mortality across screening populations. However, a clinical need persists for more accessible, cost-effective, and robust approaches for increased-risk and diverse patient populations, especially those with dense breasts where screening mammography is suboptimal. We developed and validated a cost-effective, portable, patient-dedicated three-dimensional (3D) automated breast ultrasound (ABUS) system for point-of-care breast cancer screening. The 3D ABUS system contains a wearable, rapid-prototype 3D-printed dam assembly, a compression assembly, and a computer-driven 3DUS scanner, adaptable to any commercially available US machine and transducer. Acquisition is operator-agnostic, involves a 40-second scan time, and provides multiplanar 3D visualization for whole-breast assessment. Geometric reconstruction accuracy was evaluated with a 3D grid phantom and tissue-mimicking breast phantoms, demonstrating linear measurement and volumetric reconstruction errors < 0.2 mm and < 3%, respectively. The system's capability was demonstrated in a healthy male volunteer and two healthy female volunteers, representing diverse patient geometries and breast sizes. The system enables comfortable ultrasonic coupling and tissue stabilization, with adjustable compression to improve image quality while alleviating discomfort. Moreover, the system effectively mitigates breathing and motion, since its assembly affixes directly onto the patient. While future studies are still required to evaluate the impact on current clinical practices and workflow, the 3D ABUS system shows potential for adoption as an alternative, cost-effective, dedicated point-of-care breast cancer screening approach for increased-risk populations and limited-resource settings.

Toward mechatronic MRI-guided focal laser ablation of the prostate: Robust registration for improved needle delivery.

BACKGROUND: Multiparametric MRI (mpMRI) is an effective tool for detecting and staging prostate cancer (PCa), guiding interventional therapy, and monitoring PCa treatment outcomes. MRI-guided focal laser ablation (FLA) therapy is an alternative, minimally invasive treatment method to conventional therapies, which has been demonstrated to control low-grade, localized PCa while preserving patient quality of life. The therapeutic success of FLA depends on the accurate placement of needles for adequate delivery of ablative energy to the target lesion. We previously developed an MR-compatible mechatronic system for prostate FLA needle guidance and validated its performance in open-air and clinical 3T in-bore experiments using virtual targets. PURPOSE: To develop a robust MRI-to-mechatronic system registration method and evaluate its in-bore MR-guided needle delivery accuracy in tissue-mimicking prostate phantoms. METHODS: The improved registration multifiducial assembly houses thirty-six aqueous gadolinium-filled spheres distributed over a 7.3 × 7.3 × 5.2 cm volume. MRI-guided needle guidance accuracy was quantified in agar-based tissue-mimicking prostate phantoms on trajectories (N = 44) to virtual targets covering the mechatronic system's range of motion. 3T gradient-echo recalled (GRE) MRI images were acquired after needle insertions to each target, and the air-filled needle tracks were segmented. Needle guidance error was measured as the shortest Euclidean distance between the target point and the segmented needle trajectory, and angular error was measured as the angle between the targeted trajectory and the segmented needle trajectory. These measurements were made using both the previously designed four-sphere registration fiducial assembly on trajectories (N = 7) and compared with the improved multifiducial assembly using a Mann-Whitney U test. RESULTS: The median needle guidance error of the system using the improved registration fiducial assembly at a depth of 10 cm was 1.02 mm with an interquartile range (IQR) of 0.42-2.94 mm. The upper limit of the one-sided 95% prediction interval of needle guidance error was 4.13 mm. The median (IQR) angular error was 0.0097 rad (0.0057-0.015 rad) with a one-sided 95% prediction interval upper limit of 0.022 rad. The median (IQR) positioning error using the previous four-sphere registration fiducial assembly was 1.87 mm (1.77-2.14 mm). This was found to be significantly different (p = 0.0012) from the median (IQR) positioning error of 0.28 mm (0.14-0.95 mm) using the new registration fiducial assembly on the same trajectories. No significant difference was detected between the medians of the angular errors (p = 0.26). CONCLUSION: This is the first study presenting an improved registration method and validation in tissue-mimicking phantoms of our remotely actuated MR-compatible mechatronic system for delivery of prostate FLA needles. Accounting for the effects of needle deflection, the system was demonstrated to be capable of needle delivery with an error of 4.13 mm or less in 95% of cases under ideal conditions, which is a statistically significant improvement over the previous method. The system will next be validated in a clinical setting.

Spatially tracked whole-breast three-dimensional ultrasound system toward point-of-care breast cancer screening in high-risk women with dense breasts.

BACKGROUND: Mammographic screening has reduced mortality in women through the early detection of breast cancer. However, the sensitivity for breast cancer detection is significantly reduced in women with dense breasts, in addition to being an independent risk factor. Ultrasound (US) has been proven effective in detecting small, early-stage, and invasive cancers in women with dense breasts. PURPOSE: To develop an alternative, versatile, and cost-effective spatially tracked three-dimensional (3D) US system for whole-breast imaging. This paper describes the design, development, and validation of the spatially tracked 3DUS system, including its components for spatial tracking, multi-image registration and fusion, feasibility for whole-breast 3DUS imaging and multi-planar visualization in tissue-mimicking phantoms, and a proof-of-concept healthy volunteer study. METHODS: The spatially tracked 3DUS system contains (a) a six-axis manipulator and counterbalanced stabilizer, (b) an in-house quick-release 3DUS scanner, adaptable to any commercially available US system, and removable, allowing for handheld 3DUS acquisition and two-dimensional US imaging, and (c) custom software for 3D tracking, 3DUS reconstruction, visualization, and spatial-based multi-image registration and fusion of 3DUS images for whole-breast imaging. Spatial tracking of the 3D position and orientation of the system and its joints (J1-6 ) were evaluated in a clinically accessible workspace for bedside point-of-care (POC) imaging. Multi-image registration and fusion of acquired 3DUS images were assessed with a quadrants-based protocol in tissue-mimicking phantoms and the target registration error (TRE) was quantified. Whole-breast 3DUS imaging and multi-planar visualization were evaluated with a tissue-mimicking breast phantom. Feasibility for spatially tracked whole-breast 3DUS imaging was assessed in a proof-of-concept healthy male and female volunteer study. RESULTS: Mean tracking errors were 0.87 ± 0.52, 0.70 ± 0.46, 0.53 ± 0.48, 0.34 ± 0.32, 0.43 ± 0.28, and 0.78 ± 0.54 mm for joints J1-6 , respectively. Lookup table (LUT) corrections minimized the error in joints J1 , J2 , and J5 . Compound motions exercising all joints simultaneously resulted in a mean tracking error of 1.08 ± 0.88 mm (N = 20) within the overall workspace for bedside 3DUS imaging. Multi-image registration and fusion of two acquired 3DUS images resulted in a mean TRE of 1.28 ± 0.10 mm. Whole-breast 3DUS imaging and multi-planar visualization in axial, sagittal, and coronal views were demonstrated with the tissue-mimicking breast phantom. The feasibility of the whole-breast 3DUS approach was demonstrated in healthy male and female volunteers. In the male volunteer, the high-resolution whole-breast 3DUS acquisition protocol was optimized without the added complexities of curvature and tissue deformations. With small post-acquisition corrections for motion, whole-breast 3DUS imaging was performed on the healthy female volunteer showing relevant anatomical structures and details. CONCLUSIONS: Our spatially tracked 3DUS system shows potential utility as an alternative, accurate, and feasible whole-breast approach with the capability for bedside POC imaging. Future work is focused on reducing misregistration errors due to motion and tissue deformations, to develop a robust spatially tracked whole-breast 3DUS acquisition protocol, then exploring its clinical utility for screening high-risk women with dense breasts.

Feasibility of fusing three-dimensional transabdominal and transrectal ultrasound images for comprehensive intraoperative visualization of gynecologic brachytherapy applicators.

PURPOSE: In this study, we propose combining three-dimensional (3D) transrectal ultrasound (TRUS) and 3D transabdominal ultrasound (TAUS) images of gynecologic brachytherapy applicators to leverage the advantages of each imaging perspective, providing a broader field-of-view and allowing previously obscured features to be recovered. The aim of this study was to evaluate the feasibility of fusing these 3D ultrasound (US) perspectives based on the applicator geometry in a phantom prior to clinical implementation. METHODS: In proof-of-concept experiments, 3D US images of application-specific multimodality pelvic phantoms were acquired with tandem-and-ring and tandem-and-ovoids applicators using previously validated imaging systems. Two TRUS images were acquired at different insertion depths and manually fused based on the position of the ring/ovoids to broaden the TRUS field-of-view. The phantom design allowed "abdominal thickness" to be modified to represent different body habitus and TAUS images were acquired at three thicknesses for each applicator. The merged TRUS images were then combined with TAUS images by rigidly aligning applicator components and manually refining the registration using the positions of source channels and known tandem length, as well as the ring diameter for the tandem-and-ring applicator. Combined 3D US images were manually, rigidly registered to images from a second modality (magnetic resonance (MR) imaging for the tandem-and-ring applicator and X-ray computed tomography (CT) for the tandem-and-ovoids applicator (based on applicator compatibility)) to assess alignment. Four spherical fiducials were used to calculate target registration errors (TREs), providing a metric for validating registrations, where TREs were computed using root-mean-square distances to describe the alignment of manually identified corresponding fiducials. An analysis of variance (ANOVA) was used to identify statistically significant differences (p < 0.05) between the TREs for the three abdominal thicknesses for each applicator type. As an additional indicator of geometric accuracy, the bladder was segmented in the 3D US and corresponding MR/CT images, and volumetric differences and Dice similarity coefficients (DSCs) were calculated. RESULTS: For both applicator types, the combination of 3D TRUS with 3D TAUS images allowed image information obscured by the shadowing artifacts under single imaging perspectives to be recovered. For the tandem-and-ring applicator, the mean ± one standard deviation (SD) TREs from the images with increasing thicknesses were 1.37 ± 1.35 mm, 1.84 ± 1.22 mm, and 1.60 ± 1.00 mm. Similarly, for the tandem-and-ovoids applicator, the mean ± SD TREs from the images with increasing thicknesses were 1.37 ± 0.35 mm, 1.95 ± 0.90 mm, and 1.61 ± 0.76 mm. No statistically significant difference was detected in the TREs for the three thicknesses for either applicator type. The mean volume differences for the bladder segmentations were 3.14% and 2.33% and mean DSCs were 87.8% and 87.7% for the tandem-and-ring and tandem-and-ovoids applicators, respectively. CONCLUSIONS: In this proof-of-concept study, we demonstrated the feasibility of fusing 3D TRUS and 3D TAUS images based on the geometry of tandem-and-ring and tandem-and-ovoids applicators. This represents a step toward an accessible and low-cost 3D imaging method for gynecologic brachytherapy, with the potential to extend this approach to other intracavitary configurations and hybrid applicators.

Design and validation of an MRI-compatible mechatronic system for needle delivery to localized prostate cancer.

PURPOSE: Prostate cancer is the most common non-cutaneous cancer among men in the United States and is the second leading cause of cancer death in American men. (Siegel et al. [2019] CA: A Cancer J Clin.69(1):7-34.) Focal laser ablation (FLA) has the potential to control small tumors while preserving urinary and erectile function by leaving the neurovascular bundles and urethral sphincters intact. Accurate needle guidance is critical to the success of FLA. Multiparametric magnetic resonance images (mpMRI) can be used to identify targets, guide needles, and assess treatment outcomes. The purpose of this work was to design and evaluate the accuracy of an MR-compatible mechatronic system for in-bore transperineal guidance of FLA ablation needles to localized lesions in the prostate. METHODS: The mechatronic system was constructed entirely of non-ferromagnetic materials, with actuation controlled by piezoelectric motors and optical encoders. The needle guide hangs between independent front and rear two-link arms, which allows for horizontal and vertical translation as well as pitch and yaw rotation of the guide with a 6.0 cm range of motion in each direction. Needles are inserted manually through a chosen hole in the guide, which has been aligned with the target in the prostate. Open-air positioning error was evaluated using an optical tracking system (0.25 mm RMS accuracy) to measure 125 trajectories in free space. Correction of systematic bias in the system was performed using 85 of the trajectories, and the remaining 40 were used to estimate the residual error. The error was calculated as the horizontal and vertical displacement between the axis of the desired and measured trajectories at a typical needle insertion depth of 10 cm. MR-compatibility was evaluated using a grid phantom to assess image degradation due to the presence of the system, and induced force, heating, and electrical interference in the system were assessed qualitatively. In-bore positioning error was evaluated on 25 trajectories. RESULTS: Open-air mean positioning error at the needle tip was 0.80 ± 0.36 mm with a one-sided 95% confidence interval of 1.40 mm. The mean deviation of needle trajectories from the planned direction was 0.14 ± 0.06∘ . In the MR bore, the mean positioning error at the needle tip was 2.11 ± 1.05 mm with a one-sided 95% prediction interval of 3.84 mm. The mean angular error was 0.49 ± 0.26∘ . The system was found to be compatible with the MR environment under the specified gradient-echo sequence parameters used in this study. CONCLUSION: A complete system for delivering needles to localized prostate tumors was developed and described in this work, and its compatibility with the MR environment was demonstrated. In-bore MRI positioning error was sufficiently small for targeting small localized prostate tumors.

Development of a mechatronic guidance system for targeted ultrasound-guided biopsy under high-resolution positron emission mammography localization.

PURPOSE: Image-guided needle biopsy of small, detectable lesions is crucial for early-stage diagnosis, treatment planning, and management of breast cancer. High-resolution positron emission mammography (PEM) is a dedicated functional imaging modality that can detect breast cancer independent of breast tissue density, but anatomical context and real-time needle visualization are not yet available to guide biopsy. We propose a mechatronic guidance system integrating an ultrasound (US)-guided core-needle biopsy (CNB) with high-resolution PEM localization to improve the spatial sampling of breast lesions. This paper presents the benchtop testing and phantom studies to evaluate the accuracy of the system and its constituent components for targeted PEM-US-guided biopsy under simulated high-resolution PEM localization. METHODS: A mechatronic guidance system was developed to operate with the Radialis PEM system and a conventional US system. The system includes a user-operated guidance arm and end-effector biopsy device, integrating a US transducer and CNB gun, with its needle focused on a remote center of motion (RCM). Custom software modules were developed to track, display, and guide the end-effector biopsy device. Registration of the mechatronic guidance system to a simulated PEM detector plate was performed using a landmark-based method. Testing was performed with fiducials positioned in the peripheral and central regions of the simulated detector plate and registration error was quantified. Breast phantom experiments were performed under ideal detection and localization to evaluate for bias in the end-effector biopsy device. The accuracy of the complete mechatronic guidance system to perform targeted breast biopsy was assessed using breast phantoms with simulated lesions. Three-dimensional positioning error was quantified, and principal component analysis assessed for directional trends in 3D space within 95% prediction intervals. Targeted breast biopsies with test phantoms were performed and an overall in-plane needle targeting error was quantified. RESULTS: The mean registration errors were 0.63 mm (N = 44) and 0.73 mm (N = 72) in the peripheral and central regions of the simulated PEM detector plate, respectively. A 3D 95% prediction ellipsoid shows an error volume <2.0 mm in diameter, centered on the mean registration error. Under ideal detection and localization, targets <1.0 mm in diameter can be sampled with 95% confidence. The complete mechatronic guidance system was able to successfully spatially sample simulated breast lesions, 4 mm and 6 mm in diameter and height (N = 20) in known 3D positions in the PEM image coordinate space. The 3D positioning error was 0.85 mm (N = 20) with 0.64 mm in-plane and 0.44 mm cross-plane component errors. Targeted breast biopsies resulted in a mean in-plane needle targeting error of 1.08 mm (N = 15) allowing for targets 1.32 mm in radius to be sampled with 95% confidence. CONCLUSIONS: We demonstrated the utility of our mechatronic guidance system for targeted breast biopsy under high-resolution PEM localization. Breast phantom studies showed the ability to accurately guide, position, and target breast lesions with the accuracy to spatially sample targets <3.0 mm in diameter with 95% confidence. Future work will integrate the developed system with the Radialis PEM system toward combined PEM-US-guided breast biopsy.

Intraoperative 360-deg three-dimensional transvaginal ultrasound during needle insertions for high-dose-rate transperineal interstitial gynecologic brachytherapy of vaginal tumors.

Brachytherapy, a type of radiotherapy, may be used to place radioactive sources into or in close proximity to tumors, providing a method for conformally escalating dose in the tumor and the local area surrounding the malignancy. High-dose-rate interstitial brachytherapy of vaginal tumors requires precise placement of multiple needles through holes in a plastic perineal template to deliver treatment while optimizing dose and avoiding overexposure of nearby organs at risk (OARs). Despite the importance of needle placement, image guidance for adaptive, intraoperative needle visualization, allowing misdirected needles to be identified and corrected during insertion, is not standard practice. We have developed a 360-deg three-dimensional (3-D) transvaginal ultrasound (TVUS) system using a conventional probe with a template-compatible custom sonolucent vaginal cylinder and propose its use for intraoperative needle guidance during interstitial gynecologic brachytherapy. We describe the 3-D TVUS mechanism and geometric validation, present mock phantom procedure results, and report on needle localization accuracy in patients. For the six patients imaged, landmark anatomical features and all needles were clearly visible. The implementation of 360-deg 3-D TVUS through a sonolucent vaginal cylinder provides a technique for visualizing needles and OARs intraoperatively during interstitial gynecologic brachytherapy, enabling implants to be assessed and providing the potential for image guidance.

Design, development and evaluation of a compact telerobotic catheter navigation system.

BACKGROUND: Remote catheter navigation systems protect interventionalists from scattered ionizing radiation. However, these systems typically require specialized catheters and extensive operator training. METHODS: A new compact and sterilizable telerobotic system is described, which allows remote navigation of conventional tip-steerable catheters, with three degrees of freedom, using an interface that takes advantage of the interventionalist's existing dexterity skills. The performance of the system is evaluated ex vivo and in vivo for remote catheter navigation and ablation delivery. RESULTS: The system has absolute errors of 0.1 ± 0.1 mm and 7 ± 6° over 100 mm of axial motion and 360° of catheter rotation, respectively. In vivo experiments proved the safety of the proposed telerobotic system and demonstrated the feasibility of remote navigation and delivery of ablation. CONCLUSION: The proposed telerobotic system allows the interventionalist to use conventional steerable catheters; while maintaining a safe distance from the radiation source, he/she can remotely navigate the catheter and deliver ablation lesions. Copyright © 2015 John Wiley & Sons, Ltd.

3D image-guided robotic needle positioning system for small animal interventions.

PURPOSE: This paper presents the design of a micro-CT guided small animal robotic needle positioning system. In order to simplify the robotic design and maintain a small targeting error, a novel implementation of the remote center of motion is used in the system. The system has been developed with the objective of achieving a mean targeting error of <200 µm while maintaining a high degree of user friendliness. METHODS: The robot is compact enough to operate within a 25 cm diameter micro-CT bore. Small animals can be imaged and an intervention performed without the need to transport the animal from one workspace to another. Not requiring transport of the animal reduces opportunities for targets to shift from their localized position in the image and simplifies the workflow of interventions. An improved method of needle calibration is presented that better characterizes the calibration using the position of the needle tip in photographs rather than the needle axis. A calibration fixture was also introduced, which dramatically reduces the time requirements of calibration while maintaining calibration accuracy. Two registration modes have been developed to correspond the robot coordinate system with the coordinate system of the micro-CT scanner. The two registration modes offer a balance between the time required to complete a registration and the overall registration accuracy. The development of slow high accuracy and fast low accuracy registration modes provides users with a degree of flexibility in selecting a registration mode best suited for their application. RESULTS: The target registration error (TRE) of the higher accuracy primary registration was TRE(primary) = 31 ± 12 µm. The error in the lower accuracy combined registration was TRE(combined) = 139 ± 63 µm. Both registration modes are therefore suitable for small-animal needle interventions. The targeting accuracy of the robotic system was characterized using targeting experiments in tissue-mimicking gelatin phantoms. The results of the targeting experiments were combined with the known calibration and needle deflection errors to provide a more meaningful measure of the needle positioning accuracy of the system. The combined targeting errors of the system were 149 ± 41 µm and 218 ± 38 µm using the primary and combined registrations, respectively. Finally, pilot in vivo experiments were successfully completed to demonstrate the performance of the system in a biomedical application. CONCLUSIONS: The device was able to achieve the desired performance with an error of <200 µm and improved repeatability when compared to other designs. The device expands the capabilities of image-guided interventions for preclinical biomedical applications.

A system for MRI-guided transperineal delivery of needles to the prostate for focal therapy.

PURPOSE: To demonstrate the capabilities of a new magnetic resonance imaging (MRI)-guided system for delivering needles to the prostate for focal therapy. Included is a presentation of the design of the system and its user interface, evaluation of MR-compatibility, and quantitative evaluation of guidance accuracy and repeatability within the bore of a clinical MRI scanner. METHODS: The use of MRI for visualization of tumors, intraoperative visualization of interventional tools, and thermometry for controlled ablation of lesions is becoming increasingly prevalent. In this work, the authors present a prototype system for guiding needles to prostate tumors within the bore of an MRI scanner for use in focal laser thermal ablation of prostate tumors. The system consists of a manually actuated trajectory alignment device that allows a physician to precisely align a set of needle guides with an intended target in the prostate within the bore of a clinical closed-bore MRI scanner. Needle insertion is then performed transperineally, with the patient in the bore of the MRI, and custom software provides monitoring of thermal ablative procedures. RESULTS: The system is shown to have a minimal effect on image distortion, and only a 6% decrease in image signal-to-noise ratio. Through needle insertion tests in tissue-mimicking phantoms, the system's potential for reliably guiding needles to intra-MR targets within 2.64 mm has been demonstrated. Use of the system to deliver focal laser ablation therapy to two patients showed that it can be used to deliver needles with minimal disruption of workflow, and in less time than when insertions are performed freehand or with a fixed grid template. CONCLUSIONS: A system for delivering needles to a patient's prostate for focal therapy within the bore of an MRI scanner has been developed. Results from needle insertion tests in phantoms suggest that the system has the potential to provide accurate delivery of focal therapy to prostate tumors of the smallest clinically significant size. Initial tests in two patients showed that needle deflection was larger than in phantoms, but methods of manually compensating for this effect were employed and needles were delivered to treatment sites with sufficient accuracy to deliver effective treatment. In addition, the treatment was delivered in less time than with a fixed grid template or freehand insertions. Despite this success, methods of reducing needle deflection are needed in order to fully utilize the potential of this system, and further reduce total procedure time.

Traceable micro-CT scaling accuracy phantom for applications requiring exact measurement of distances or volumes.

PURPOSE: Volumetric x-ray microcomputed tomography (CT) can be employed in a variety of quantitative research applications such as image-guided interventions or characterization of medical devices. To ensure the highest geometric fidelity of images for these applications, a phantom and image processing algorithm have been developed to calibrate the scaling accuracy of micro-CT scanners to a traceable standard and provide corrections to image voxel sizing. METHODS: The calibration phantom contains six borosilicate beads whose separations have been measured to a traceable standard. An image processing algorithm compares the known separations of the beads to their separations in micro-CT images. A least-squares solution is used to determine linear scaling correction factors along each of the three scanner axes to minimize errors in the bead separations within the images by correcting the image voxel size. The correction factors were applied to images of a similar phantom with beads at different positions to evaluate the ability of the correction factors to reduce errors at points independent of the fiducial locations in the calibration phantom. The calibration phantom was used to evaluate the scaling accuracy of five different micro-CT scanners representing four different scanner models. RESULTS: In two of the five scanners evaluated, the correction factors significantly reduced the mean error in bead separations in the images from 0.17% to 0.05% and from 0.37% to 0.07% of the actual bead separations, respectively. Scanners yielding similar voxel sizes possessed comparable geometric errors after correction using the phantom. CONCLUSIONS: Although the magnitude of the corrections is small, such corrections can be important for demanding micro-CT applications. Even if no voxel size correction is required, the phantom provides an easily implemented method to verify the geometric fidelity of micro-CT scanners to a traceable standard of measurement.

A compact mechatronic system for 3D ultrasound guided prostate interventions.

PURPOSE: Ultrasound imaging has improved the treatment of prostate cancer by producing increasingly higher quality images and influencing sophisticated targeting procedures for the insertion of radioactive seeds during brachytherapy. However, it is critical that the needles be placed accurately within the prostate to deliver the therapy to the planned location and avoid complications of damaging surrounding tissues. METHODS: The authors have developed a compact mechatronic system, as well as an effective method for guiding and controlling the insertion of transperineal needles into the prostate. This system has been designed to allow guidance of a needle obliquely in 3D space into the prostate, thereby reducing pubic arch interference. The choice of needle trajectory and location in the prostate can be adjusted manually or with computer control. RESULTS: To validate the system, a series of experiments were performed on phantoms. The 3D scan of the string phantom produced minimal geometric error, which was less than 0.4 mm. Needle guidance accuracy tests in agar prostate phantoms showed that the mean error of bead placement was less then 1.6 mm along parallel needle paths that were within 1.2 mm of the intended target and 1 degree from the preplanned trajectory. At oblique angles of up to 15 degrees relative to the probe axis, beads were placed to within 3.0 mm along a trajectory that were within 2.0 mm of the target with an angular error less than 2 degrees. CONCLUSIONS: By combining 3D TRUS imaging system to a needle tracking linkage, this system should improve the physician's ability to target and accurately guide a needle to selected targets without the need for the computer to directly manipulate and insert the needle. This would be beneficial as the physician has complete control of the system and can safely maneuver the needle guide around obstacles such as previously placed needles.

Quantification of prostate deformation due to needle insertion during TRUS-guided biopsy: comparison of hand-held and mechanically stabilized systems.

PURPOSE: Prostate biopsy is the clinical standard for the definitive diagnosis of prostate cancer. To overcome the limitations of 2D TRUS-guided biopsy systems when targeting preplanned locations, systems have been developed with 3D guidance to improve the accuracy of cancer detection. Prostate deformation due to needle insertion and biopsy gun firing is a potential source of error that can cause target misalignments during biopsies. METHODS: The authors used nonrigid registration of 2D TRUS images to quantify the deformation that occurs during the needle insertion and the biopsy gun firing procedure and compare this effect in biopsies performed using a hand-held TRUS probe to those performed using a mechanically assisted 3D TRUS-guided biopsy system. The authors calculated a spatially varying 95% confidence interval on the prostate tissue motion and analyzed this motion both as a function of distance to the biopsy needle and as a function of distance to the lower piercing point of the prostate. The former is relevant because biopsy targets lie along the needle axis, and the latter is of particular importance due to the reported high concentration of prostate cancer in the peripheral zone, a substantial portion of which lies on the posterior side of the prostate where biopsy needles enter the prostate after penetrating the rectal wall during transrectal biopsy. RESULTS: The results show that for both systems, the tissue deformation is such that throughout the length of the needle axis, including regions proximal to the lower piercing point, spherical tumors with a radius of 2.1 mm or more can be sampled with 95% confidence under the assumption of zero error elsewhere in the biopsy system. More deformation was observed in the direction orthogonal to the needle axis compared to the direction parallel to the needle axis; this is of particular importance given the long, narrow shape of the biopsy core. The authors measured lateral tissue motion proximal to the needle axis of not more than 1.5 mm, with 95% confidence. The authors observed a statistically significant and clinically insignificant maximum difference of 0.38 mm in the deformation, resulting from the hand-held and mechanically assisted systems along the needle axis, and the mechanical system resulted in a lower relative increase in deformation proximal to the needle axis during needle insertion, as well as lower variability of deformation during biopsy gun firing. CONCLUSIONS: Given the clinical need to biopsy tumors of volume greater than or equal to 0.5 cm3, corresponding to spherical tumors with a radius of 5 mm or more, the tissue motion induced by needle insertion and gun firing is an important consideration when setting the design specifications for TRUS-guided prostate biopsy systems.

Design and performance evaluation of a remote catheter navigation system.

A novel remote catheter navigation system has been developed to reduce physical stress and irradiation to the interventionalist during fluoroscopic X-ray guided catheter intervention. The unique teleoperated design of this system allows the interventionalist to apply conventional axial and radial motion, as used in current practice, to an input catheter placed in a radiation-safe location to control a second catheter placed inside the procedure room. A catheter sensor (used to measure motion of the input catheter) and a catheter manipulator (used to manipulate the second catheter) are both presented. Performance evaluation of the system was assessed by first conducting bench-top experiments to quantify accuracy and precision of both sensed and replicated motion, and then conducting two experiments to evaluate the latency from sensed to replicated motion. The first study consisted of replicating motions of prescribed motion trajectories, while the second study utilized eight operators to remotely navigate a catheter through a normal carotid model. The results show the system has the ability to sense and replicate motion to within 1 mm and 1 ( degrees ) in the axial and radial directions, respectively. Remote catheter manipulation was found to be operator dependent and occurred under 300 ms. Future applications of this technology are then presented.

Mechanically assisted 3D ultrasound guided prostate biopsy system.

There are currently limitations associated with the prostate biopsy procedure, which is the most commonly used method for a definitive diagnosis of prostate cancer. With the use of two-dimensional (2D) transrectal ultrasound (TRUS) for needle-guidance in this procedure, the physician has restricted anatomical reference points for guiding the needle to target sites. Further, any motion of the physician's hand during the procedure may cause the prostate to move or deform to a prohibitive extent. These variations make it difficult to establish a consistent reference frame for guiding a needle. We have developed a 3D navigation system for prostate biopsy, which addresses these shortcomings. This system is composed of a 3D US imaging subsystem and a passive mechanical arm to minimize prostate motion. To validate our prototype, a series of experiments were performed on prostate phantoms. The 3D scan of the string phantom produced minimal geometric distortions, and the geometric error of the 3D imaging subsystem was 0.37 mm. The accuracy of 3D prostate segmentation was determined by comparing the known volume in a certified phantom to a reconstructed volume generated by our system and was shown to estimate the volume with less then 5% error. Biopsy needle guidance accuracy tests in agar prostate phantoms showed that the mean error was 2.1 mm and the 3D location of the biopsy core was recorded with a mean error of 1.8 mm. In this paper, we describe the mechanical design and validation of the prototype system using an in vitro prostate phantom. Preliminary results from an ongoing clinical trial show that prostate motion is small with an in-plane displacement of less than 1 mm during the biopsy procedure.