MARIA® M5: A multicentre clinical study to evaluate the ability of the Micrima radio-wave radar breast imaging system (MARIA®) to detect lesions in the symptomatic breast.

The MARIA® breast imaging system is a clinical diagnostic tool that uses a hemispherical array of radiowave antennas to generate three-dimensional images of the internal breast. The system utilises the variance of dielectric contrast within the breast volume in order to identify areas of interest for further diagnostic investigation. This multicentre study of 225 patients was conducted at three trial sites and recruited women with both malignant and benign lesions. The MARIA® images from the study were read by both clinicians who had access to the patient's clinical information, as well as by 'blind' reviewers who did not. Results from the study show an overall sensitivity of 76% for the system, which was similar across benign and malignant findings, and in denser breasts. The results from this study are outlined here and discussions on ongoing and future work with MARIA® are deliberated.

Correction to: Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations.

The article "Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations", written by Barbara Schwartzberg et al., was originally published electronically on the publisher's internet portal (currently SpringerLink) on July 9, 2018, without open access.

Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations.

BACKGROUND: An institutional review board-approved, multicenter clinical trial was designed to determine the efficacy and outcome of percutaneous laser ablation (PLA) in the treatment of invasive ductal breast carcinoma (IDC). Post-ablation magnetic resonance imaging (MRI) was compared with surgical pathology in evaluation of residual post-ablation IDC and ductal carcinoma in situ. METHODS: Patients with a single focus of IDC 20 mm or smaller by pre-ablation MRI were treated with PLA. The patients underwent a 28-day post-ablation MRI, followed by surgical resection. Cell viability criteria were applied to pre- and post-ablation pathology specimens, which evaluated hematoxylin-eosin (H&E), cytokeratin (CK) 8/18, estrogen receptor, and Ki67 staining patterns. RESULTS: In this study, 61 patients were reported as the intention-to-treat cohort for determination of PLA efficacy. Of these 61 patients, 51 (84%) had complete tumor ablation confirmed by pathology analysis. One subject's MRI imaging was not performed per protocol, which left 60 subjects evaluable for MRI pathology correlation. Five patients (8.3%) had residual IDC shown by both MRI and pathology. Post-ablation discordance was noted between MRI and pathology, with four patients (6.7%) false-positive and four patients (6.7%) false-negative. The negative predictive value (NPV) of MRI for all the patients was 92.2% (95% confidence interval [CI], 71.9-91.9%). Of the 47 patients (97.9%) with tumors 15 mm or smaller, 46 were completely ablated, with an MRI NPV of 97.7% (95% CI, 86.2-99.9%). CONCLUSIONS: Percutaneous laser ablation is a potential alternative to surgery for treatment of early-stage IDC. Strong correlations exist between post-ablation MRI and pathologic alterations in CK8/18, ER, and Ki67 staining.

MARIA M4: clinical evaluation of a prototype ultrawideband radar scanner for breast cancer detection.

A microwave imaging system has been developed as a clinical diagnostic tool operating in the 3- to 8-GHz region using multistatic data collection. A total of 86 patients recruited from a symptomatic breast care clinic were scanned with a prototype design. The resultant three-dimensional images have been compared "blind" with available ultrasound and mammogram images to determine the detection rate. Images show the location of the strongest signal, and this corresponded in both older and younger women, with sensitivity of [Formula: see text], which was found to be maintained in dense breasts. The pathway from clinical prototype to clinical evaluation is outlined.

The impact of the 21-gene assay on adjuvant treatment decisions in oestrogen receptor-positive early breast cancer: a prospective study.

BACKGROUND: International guidelines, including NICE, recommend using the 21-gene Recurrence Score assay for guiding adjuvant treatment decisions in ER+, HER2-negative early breast cancer (BC). We investigated the impact of adding this assay to standard pathological tests on clinicians'/patients' treatment decisions and on patients' decisional conflict in the United Kingdom. METHODS: In this prospective multicentre study, eligibility criteria included: ER+ HER2-negative BC (N0/Nmic for patients ⩽50 years; ⩽3 positive lymph nodes for patients >50 years) and being fit for chemotherapy. Physicians'/patients' treatment choices and patients' decisional conflict were recorded pre- and post testing. RESULTS: The analysis included 137 patients. Overall, adjuvant treatment recommendations changed in 40.7% of patients, with the direction of the change consistent with the Recurrence Score results (net decrease in chemotherapy recommendation rate in low Recurrence Score patients and net increase in high Recurrence Score patients). Patients' choices were generally consistent with physicians' recommendations. Post-testing, patients' decisional conflict decreased significantly (P<0.0001). In the 67 patients meeting the NICE criteria for testing, the recommendation change rate was 49.3%. CONCLUSIONS: Recurrence Score testing significantly influenced treatment recommendations overall and in the subgroup of patients meeting the NICE criteria, suggesting that this test could substantially alter treatment patterns in the United Kingdom.

Coherent ultrasonic Doppler tomography.

Ultrasonic imaging based on the pulse-echo principle is widely used throughout the world, particularly in medical applications. However, its spatial resolution is poor (around 2 times the wavelength, or 200 µm at 15 MHz), limiting its ability to detect small but clinically important lesions (such as microcalcifications in breast cancer). The work presented here is different from the traditional approach. Continuous-wave ultrasound is transmitted to insonate a rotating object, then the amplitude and phase of the returned signals are coherently processed to reconstruct a Doppler tomographic image of the object's backscatter field. It is demonstrated numerically that the spatial resolution is up to 0.19 wavelengths and the sampling requirement and image formation method are given. To show the performance of the method, we present the results obtained by applying the new technique in simulation and experiment. A string phantom consisting of very thin copper wires and two cylindrical phantoms constructed by tissue-mimicking-material were scanned. It is demonstrated that the copper wires were located very accurately with very high spatial resolution, and good shape approximation for the cylindrical phantoms was achieved.

Referral patterns, cancer diagnoses, and waiting times after introduction of two week wait rule for breast cancer: prospective cohort study.

OBJECTIVE: To investigate the long term impact of the two week wait rule for breast cancer on referral patterns, cancer diagnoses, and waiting times. DESIGN: Prospective cohort study. SETTING: A specialist breast clinic in a teaching hospital in Bristol. PARTICIPANTS: All patients referred to breast clinic from primary care between 1999 and 2005. MAIN OUTCOME MEASURES: Number, route, and outcome of referrals from primary care and waiting times for urgent and routine appointments. RESULTS: The annual number of referrals increased by 9% over the seven years from 3499 in 1999 to 3821 in 2005. Routine referrals decreased by 24% (from 1748 to 1331), but two week wait referrals increased by 42% (from 1751 to 2490) during this time. The percentage of patients diagnosed with cancer in the two week wait group decreased from 12.8% (224/1751) in 1999 to 7.7% (191/2490) in 2005 (P<0.001), while the number of cancers detected in the "routine" group increased from 2.5% (43/1748) to 5.3% (70/1331) (P<0.001) over the same period. About 27% (70/261) of people with cancer are currently referred in the non-urgent group. Waiting times for routine referrals have increased with time. CONCLUSION: The two week wait rule for breast cancer is failing patients. The number of cancers detected in the two week wait population is decreasing, and an unacceptable proportion is now being referred via the routine route. If breast cancer services are to be improved, the two week wait rule should be reviewed urgently.