[The "EVA" Trial: Evaluation of the Efficacy of Diagnostic Methods (Mammography, Ultrasound, MRI) in the secondary and tertiary prevention of familial breast cancer. Preliminary results after the first half of the study period]. / Die "EVA"-Studie: Evaluierung der Leistungsfähigkeit diagnostischer Verfahren (Mammographie, Sonographie, MRT) zur sekundären und tertiären Prävention des familiären Mammakarzinoms -- Zwischenergebnisse nach der ersten Hälfte der Förderungsperiode.

PURPOSE: To investigate the respective diagnostic accuracies of the different breast imaging modalities, i. e., mammography (Mx), high-frequency breast ultrasound (US), and dynamic contrast-enhanced breast (MRI) regarding the early diagnosis of familial (hereditary) breast cancer. MATERIALS AND METHODS: A prospective, non-randomized controlled clinical multi-center trial is performed at 4 academic tertiary care centers in Germany (Ulm, Munchen/Grosshadern, Munster and Bonn) for a total period of 4 years, sponsored by the German Cancer Aid. The protocol consists of semiannual clinical visits and breast ultrasound, and annual bilateral two-view Mx, US and MRI. Imaging studies were first analyzed independently, then Mx was read in conjunction with US, followed by Mx combined with MRI, and finally, all three imaging modalities were read in synopsis. We present the concept and first results of this trial. RESULTS: So far, 748 screening rounds are available for analysis in 613 women. A total of 12 breast cancers have been identified, with 11/12 cases in the pTis or pT1/N0 stage. The mean size of detected invasive cancers was 7 mm. A total of 19 benign lesions were biopsied due to false-positive imaging diagnoses. The breast cancer detection rates were: Mx: 5/12 (42 %), US 3/12 (25 %), MRI 10/12 (83 %), and the positive predictive values: Mx 5/17 (29 %), US 3/15 (30 %), and MRI 10/23 (43 %). CONCLUSION: The preliminary data suggest that early diagnosis of familial breast cancer is feasible by intensified surveillance, in particular with the addition of MRI.

[Clip marker placement following MR-guided vacuum biopsy of the breast]. / Clipmarkierung nach MRT-gesteuerter Vakuumbiopsie der Mamma.

PURPOSE: The purpose of our study was to determine the placement accuracy, usefulness as a guide for wire localization, and long-term stability of tissue marker clips following MR-guided vacuum-assisted biopsy (VB) of breast lesions. METHODS: During a 2-year period, MR-guided VB with an 11-gauge device was performed in 79 lesions. In 26 lesions a marker clip was placed at the biopsy site. RESULTS: In 18 cases, the clip was shown to be closely adjacent to the lesion on post-interventional MR images. In seven cases in which minor bleeding occurred, the clip dislocated (< or =15 mm) in the direction of the needle pathway. In one case dislocation in the dorsal direction (< or =5 mm) was observed. In eight cases with a malignant or borderline histology according to the VB, the marker clips served as targets for mammographically guided wire localization. In all of those patients, histology results derived from open surgery confirmed those of VB. Eighteen patients with benign findings according to the VB were followed up 6 months later. Among these cases we found a significant displacement of the marker clip in one case (3 cm). The clip generally caused a round artifact (diameter of 9+/-2 mm). In two cases it was not possible to determine whether the lesion had been removed completely or was just behind the artifact caused by the clip. CONCLUSION: Based on our results, clip marker placement following MR-guided vacuum biopsy should be called into question due to the possibility of masking the lesion by a metallic artifact and because of possible dislocation.

The clinical value of preoperative wire localization of breast lesions by magnetic resonance imaging--a multicenter study.

To evaluate the clinical value of MRI guided preoperative wire localization of clinically and mammographically occult lesions of the breast. In a multicenter study, we evaluated 132 preoperative MRI guided localizations. Median lesion size evaluated by MRI prior to wire localization was 9mm. MRI guided localization was successfully performed in 96.2% of cases. Median wire deviation from the lesion was 0 (0-10) mm. Moderate bleeding with no further treatment required occurred in three patients. We conclude that MRI guided preoperative wire localization is a safe and accurate procedure in cases of clinically and mammographically occult lesions of the breast.

European quadricentric evaluation of a breast MR biopsy and localization device: technical improvements based on phase-I evaluation.

Our purpose was to report about technical success, problems and solutions, as experienced in a first multicentre study on MR-guided localisation or vacuum biopsy of breast lesions. The study was carried out at four European sites using a dedicated prototype breast biopsy device. Experiences with 49 scheduled localisation procedures and 188 vacuum biopsies are reported. Apart from 35 dropped indications, one localisation procedure and 9 vacuum biopsies were not possible (3 times space problems due to obesity, 2 times too strong compression, 3 times impaired access from medially, 2 times impaired access due to a metal bar). Problems due to too strong compression were recognised by repeat MR without compression. During the procedure problems leading to an uncertain result occurred in eight vacuum biopsies, two related to the procedure: one limited access, and one strong post-biopsy enhancement. Improvements after phase-I study concerned removal of the metal bar, development of an improved medial access, of a profile imitating the biopsy gun, optimisation of compression plates and improved software support. The partners agreed that the improvements answered all important technical problems.

Multicenter study for the evaluation of a dedicated biopsy device for MR-guided vacuum biopsy of the breast.

The purpose of this multicenter study was to determine the accuracy and clinical value of a dedicated breast biopsy system which allows for MR-guided vacuum biopsy (VB) of contrast-enhancing lesions. In five European centers, MR-guided 11-gauge VB was performed on 341 lesions. In 7 cases VB was unsuccessful. This was immediately realized on postinterventional images or direct follow-up combined with histopathology-imaging correlation; thus, a false-negative diagnosis was avoided. Histology of 334 successful biopsies yielded 84 (25%) malignancies, 17 (5%) atypical ductal hyperplasias, and 233 (70%) benign entities. Verification of malignant or borderline lesions included reexcision of the biopsy cavity. Benign histologic biopsy results were verified by retrospective correlation with the pre- and postinterventional MRI and by subsequent follow-up. Our results indicate that MR-guided VB, in combination with the dedicated biopsy coil, offers the possibility to accurately diagnose even very small lesions that can only be visualized or localized by MRI.

[Stereotactic vacuum biopsy in prone and sitting position]. / Stereotaktische Vakuumbiopsie in liegender und sitzender Position.

PURPOSE: The purpose of our study was to determine the accuracy of vacuum-assisted biopsy (VB) and to evaluate the side effects of this method depending on the positioning of the patient during the intervention. METHODS: Interventions were performed with the 11-G biopsy needle either in prone position (Mammotest S, Fischer Imaging, USA) on a dedicated table for breast intervention (n = 308) or in upright position with a dedicated digital stereotactic mammography system (Mammomat 3000, Optima, Siemens, Germany). VB was indicated because of indeterminate or suspicious microcalcifications (84.1%) or because of dense lesions (15.9%). All benign results found with VB have been followed up after 6 and 12 months by mammography. All malignant or histological findings discordant to imaging features have been verified by open surgery. RESULTS: Histology after VB offered 215 (64.4%) benign lesions. In neither case a carcinoma developed during follow-up. In 90 (27%) cases malignancy was found with VB. After reexcision the diagnosis of VB was confirmed in 85.6%. In 8.9% of the cases in which VB showed DCIS, histology after open surgery revealed also invasive tumor components. Technical problems occurred in 4 cases. Major side effects developed neither in prone position nor in upright, sitting position of the patient. CONCLUSION: VB is a reliable method with less side effects for the histological evaluation of breast lesions. The accuracy and complications are not depending on the type of stereotactic device or on the patients position. The accuracy of the histological diagnosis achieved with VB can be compared to that of open surgery. The relative high costs of this method may cause a problem. But compared to the costs resulting by open diagnostic surgery this disadvantage is only a relative one.

[Minimally invasive surgical procedures of the breast: comparison of different biopsy systems in a breast parenchymal model]. / Minimal-invasive Interventionen an der Mamma: Vergleich unterschiedlicher Biopsiesysteme am Brustparenchymmodell.

PURPOSE: The purpose of our study was to evaluate various systems for large core biopsy. First to determine the volume of specimen that can be removed with each minimal-invasive method and second to compare their consistency. With respect to the optimum of volume which can be acquired the 12-G system should be optimized by special modifications. METHODS: Examinations were performed on a phantom. We used 8 automatic, one sequential-automatic and 4 halfautomatic highspeed core biopsy systems of 16-, 14- and 12 G as well as the 11G vacuum biopsy. The weight and consistency of the specimen was determined in every case. The 12G system was optimized by enlargement of the biopsy chamber. RESULTS: The 11G vacuum biopsy exhibited best results concerning the weight of the specimen (93.7 +/- 13.5 mg). The results achieved with high speed core biopsy varied with the needle diameter as well as with the technique. Semi- and halfautomatic systems were superior to automatic systems. Best results among highspeed core biopsy systems were achieved with the modified 12G biopsy needle (41.3 +/- 4.4 mg). CONCLUSION: As expected, largest volume of specimen can be removed with vacuum biopsy. High speed core biopsy systems are inferior to vacuum biopsy. Nevertheless, the amount of volume achieved can be increased to 22.4 mg by using 14G needles and to 41.3 mg by using 12G needles. The modified 12-G needle may be considered as an less expensive alternative to 11G vacuum biopsy.

MR-Guided vacuum biopsy of 206 contrast-enhancing breast lesions.

PURPOSE: To determine the accuracy and clinical use of MR-guided vacuum biopsy (VB) of enhancing breast lesions. MATERIAL AND METHODS: 254 lesions were referred to MR-guided vacuum-assisted breast biopsy. In 43 (16 %) patients the indication was dropped because the lesions could not be identified at the time VB was scheduled. This was due to hormonal influences (n = 37), to too strong compression (n = 3) or to misinterpretation of the initial diagnostic MRI (n = 3). In 5 cases (2 %) VB was not performed due to obesity (n = 2); problems of access (n = 2) or a defect of the MR-unit (n = 1). VB was performed on altogether 206 lesions. In 4 cases (2 %) VB was unsuccessful. This was immediately realized on the post-interventional images. Thus a false negative diagnosis was avoided. Verification included excision of the cavity in cases with proven malignancy or atypical ductal hyperplasia (ADH) and (for benign lesions) retrospective correlation of VB-histology with pre-and postinterventional MRI and subsequent follow-up. RESULTS: 51/202 successful biopsies proved malignancy. In 7 cases ADH and in 144 cases a benign lesion was diagnosed. One DCIS was underestimated as ADH. All other benign or malignant diagnoses proved to be correct. CONCLUSION: MR-guided VB allows reliable histological work-up of contrast-enhancing small lesions which are not visible by any other modality.

Electrical impedance measurement of the breast: effect of hormonal changes associated with the menstrual cycle.

The purpose of this study was to evaluate the influence of hormonal factors on electrical impedance measurement with a new device TS2000, which is a new method in diagnosis of breast disease. Twenty-one healthy pre-menopausal women volunteers (aged 24-39 years) were examined with the TS2000 once/week for two menstrual cycles. On average, at least one spot was present in 47% of images of women not taking oral contraceptives and in 44% of women taking oral contraceptives (OC). The number of spots varied over the menstrual cycle and had a maximum in week 3 and week 5. We found that after 1 week only 15% of spots were present and no spots persisted for three consecutive weeks. These data, if further supported by observations on other populations of women, show that false-positive results are common in pre-menopausal women; however, these false-positive spots do not persist for long periods of time. This information may provide a basis for discrimination between true-positive and false-positive spots on the TS2000 image, since the latter would be expected to disappear on short-term follow up.

[Preoperative marking and biopsy of nonpalpable breast lesions with a guidance system for the open Magnetom]. / Präoperative Markierung und Biopsie nicht palpabler Mammaläsionen mit einer Zieleinrichtung am Magnetom Open.

PURPOSE: MRI-guided interventional maneuvers in the breast, when closed MRI scanners are employed are relatively complex and time consuming. The purpose of our investigations was to develop a special device for the localization and biopsy of breast lesions using an open low-field MRI Scanner (Magnetom Open, Siemens, Erlangen, Germany) permitting free access to the patient. MATERIALS AND METHODS: Due to its particular material and construction characteristics, a newly developed device for localization and biopsy of breast lesions is appropriate to remain within the magnetic field during the examination without degrading image quality. We performed 125 tests in a phantom and 31 investigations in patients including 26 wire-localizations and 5 biopsies. RESULTS: The interventional maneuvers in the phantom could be performed very precisely. In all 125 phantom studies, the needle (14 G coaxial biopsy cannula, Bard) was positioned close to the simulated lesion. In 25 out of 26 patients the needle was positioned within a distance less than 5 mm from the lesion. When using the 14 G coaxial biopsy cannula (Bard, Karlsruhe, Germany) the needle tip was found adjacent next to the lesion in all 12 cases (7 wire-localizations, 5 biopsies). CONCLUSIONS: Our results indicate that our device allows very precise preoperative localization of breast lesions within the Magnetom Open. Using MRI-compatible, large-core needles, biopsy under direct MRI control resulted in good results.

Metastases to the breast from rhabdomyosarcoma: appearances on MRI.

The authors report a case of blood-borne bilateral metastatic breast disease of alveolar rhabdomyosarcoma (RMS) in a 21-year-old patient. The possibilities of mammography, ultrasound, and MRI in the early detection of breast metastases and their appearance on these modalities are discussed. Whereas mammography rendered no additional information due to dense breast parenchyma and ultrasound showed only a solitary tumor without definite criteria of malignancy, multifocal bilateral spread was verified with MRI and early ring-like enhancement suggested malignancy. Therefore, we conclude that MRI may provide useful information in evaluating patients with sarcomas, even when there is no clinical evidence for metastatic disease of the breast.

[Computer-assisted analysis of mammograms in routine clinical diagnosis]. / Computerassistierte Analyse von Mammographien in der klinischen Routinediagnostik.

PURPOSE: Computer-aided diagnosis in mammography is a topic many study groups have been concerned with since the first presentation of a system for computer-aided interpretation in 1967. Currently, there is only one system available for clinical use in mammaography, the CAD-System Image Checker (R2 Technology). The purpose of our prospective study was to evaluate whether the integration of the CAD-system into the routine of a radiological breast diagnosis unit is feasible. RESULTS: After the installation of the CAD-system, 300 patients with 1110 mammograms were included for evaluation in the present study. In 54 of these cases histological examination was indicated due to suspect criteria on conventional mammography. In 39 of 54 cases (72.2%) malignancy could be proven histologically. The CAD-system marked 82.1% of the histologically verified carcinomas correctly. 94.3% of all 1797 marks made by the CAD-system indicated normal or benign structures. Routinely performed CAD analysis prolonged patients waiting time by about 15 min because the marks of the CAD system had to be interpreted in addition to the routine diagnostic investigations. CONCLUSION: Our experience with the use of the CAD-system in daily routine showed that CAD analysis can easily be integrated into a preexisting mammography unit. However, the diagnostic benefit is not yet clearly established. Since the rate of false negative marks by the CAD-system Image Checker is still high, the results of CAD analysis must be checked and corrected by an observer well experienced in mammography reading.

[Dynamic MR-mammography in invasive lobular breast cancer]. / Dynamische MR-Mammographie beim invasiv lobulren Mammakarzinom bei 1,0 T.

PURPOSE: The objective of our study was to test the reliability of dynamic, contrast-enhanced MR-mammography (MR-M) in the detection of invasive lobular carcinoma (ILC) and to test if additional examination with MR-M increases the sensitivity of conventional mammography (Mx) in the detection of ILC. MATERIAL AND METHODS: We carried out 1,505 MR-Mammographies in 1,357 patients. Biopsy was indicated in 413 cases. Among the malignancies, 23/214 (10.7%) were ILC. MR-M was performed with a 1.0 T whole body MRI system with a dynamic FLASH-3D sequence. Relative signal enhancement within lesions detected and morphologic pattern of contrast enhancement (mep) were determined. Three types of mep were distinguished: type 1 without contrast enhancement, type 2 with focal contrast enhancement and type 3 with diffuse contrast enhancement of the glandular body. RESULTS: Within MR-M alone, 19/23 (82.6%) of ILC were detected due to a mep type 2. Four ILC were false negative on MR-M (2 cases show mep type 1 or mep type 3). The sensitivity of Mx alone was 86.9% (20/23). When both Mx and MR-M were combined, all 23 ILC were detected. The addition of MR-M to Mx may increase sensitivity to about 100% in the detection of ILC. CONCLUSION: Unsuspicuous MR-M (mep type 1) or diffuse uptake of contrast media (mep type 3) does not rule out malignancy in the presence of suspicious findings at Mx.

A comparison of digital luminescence mammography and conventional film - screen system: preliminary results of clinical evaluation.

The objective of this study was to determine if digital luminescence mammography can be used as a diagnostic tool. We investigated twenty-two patients with mammographically suspicious findings using a conventional film-screen system and a digital phosphor storage plate in order to compare these two techniques. Four radiologists experienced in mammography reviewed each pair of images. Our results indicate that detectability of microcalcifications and solid masses with digital systems is superior to conventional film-screen mammography due to the increased contrast enhancement associated with digital systems. We did, however, find that characterization of morphological details is inferior with the digital system, presumably due to reduced spatial resolution. In addition, we found no statistically significant difference in the differentiation of benign from malignant lesions with both techniques. The accuracy of mammographic diagnosis was investigated in a receiver operating characteristic study and similar values were found with both techniques. Our results indicate that digital mammography will become an acceptable diagnostic tool although improvement, especially in spatial resolution, is desirable.

[Preoperative marking of non-palpable mammary lesions on the magnetic resonance image using a body coil]. / Präoperative Markierung nicht-palpabler Mammaläsionen in der Magnetresonanztomographie mit der Körperspule bei 1,0 T.

PURPOSE: To evaluate the efficacy of a MRI localization procedure using a non-dedicated body coil in lesions only visible in MRI. MATERIAL AND METHODS: In 18 patients, we performed a contrast enhanced (i.v. 0.2 mmol Gd-DTPA/kg b.w.) breast MRI on a 1.0 Tesla system (Magnetom Impact, Siemens, Erlangen, Germany) using a body coil and a GRE 3D sequence. In prone position, the patients were placed in a customized positioning device offering lateral access to the breast. The localizations were done with a MRI-compatible wire (n = 21). In addition, all patients underwent the same imaging protocol using a dedicated breast coil (without localization). For both MRI modalities, the signal intensities of the lesion, the normal breast tissue, and the background noise were measured. The lesion-to-fat contrast (LFC), the lesion-to-fat contrast (LFC), the lesion-to-breast tissue contrast (LBC) and the percentage of signal change pre and post contrast administration were calculated and compared. The localisation results were correlated to pathologic findings. RESULTS: There was no difference in lesion detection (lesion size: 0.5 to 1.2 cm) between the body coil and the dedicated breast coil. Regarding the LFC and LBC, the body coil was superior to the dedicated breast coil (no statistical significance). However, the background noise was higher using the body coil. In all cases the localisation was successful. CONCLUSION: In our preliminary experience, detection of breast lesions and wire-localization of the lesion by MRI is efficient and reliable using a non-dedicated body coil.

[Computer-assisted evaluation of mammography images. Initial clinical experiences]. / Computerunterstützte Auswertung von Mammographien. Erste klinische Erfahrungen.

UNLABELLED: Preceding studies have shown that a second independent reviewer of conventional mammographies increases the detection rate of features typical for malignancy by up to 15%. METHODS: In order to test a computer-aided diagnostic (CAD) system (ImageChecker, R2 Technology, USA) for the detection of pathologic criteria in conventional mammography, 96 mammographies were retrospectively evaluated using ImageChecker. Thirty-five of these mammographies had been diagnosed as not showing pathologies, and 61 had depicted histologically confirmed malignancy. RESULTS: Detecting 41 of 61 breast malignancies, ImageChecker showed a diagnostic sensitivity of 70.5%. All malignancies accompanied by microcalcifications were identified by ImageChecker, whereas 18 cases characterized by parenchymal opacity without microcalcifications were not marked. On the average, 1.95 markers per image were set, giving a total of 187 markers in this study. 63% of all markers showed normal tissue and were thus false positive. CONCLUSIONS: Pathologic parenchymal opacities in mammography are a well-known problem for all CAD systems in use. Despite this major drawback, even now ImageChecker can provide tremendous support in routine interpretation of conventional mammographies.

[Morphology and contrast enhancement of ductal carcinoma in situ in dynamic 1.0 T MR mammography]. / Morphologie und Anreicherungsverhalten des duktalen In-situ-Karzinoms in der dynamischen MR-Mammographie bei 1,0 T.

PURPOSE: The detectability with magnetic resonance mammography (MR-M) of non-invasive ductal carcinoma in situ (DCIS), its morphology, and patterns of contrast enhancement were studied. MATERIAL AND METHODS: A total of 849 MR-M examinations were performed in 741 patients using a dynamic, contrast-enhanced FLASH 3D sequence at 1.0 T. Surgical breast biopsies were obtained in 332 cases. Histological work-up confirmed 164 carcinomas, including 20 DCIS. RESULTS: Of 20 DCIS, 14 were correctly diagnosed by MR-M on the basis of focal increase of signal intensity. In two cases (10%), no increase of signal intensity was observed. In another three cases (15%), multifocal enhancement lead to a false-negative diagnosis. In one case (5%), DCIS was a random finding in a patient diagnosed and treated for adjacent phylloides tumour. The sensitivity of MR-M was 70%. 4 (20%) of the DCIS did not show microcalcifications at conventional mammography and were only detected at MR-M. The sensitivity of conventional mammography also amounted to 70%. However, the combination of both imaging methods increased sensitivity to 90%. CONCLUSION: Ductal carcinoma in situ is not reliably detectable by MR-mammography alone due to lack of a uniform pattern of enhancement.

[MR mammography. Preoperative marking of non-palpable breast lesions with the Magnetom open at 0.2 T]. / MR-Mammographie. Präoperative Markierung nichtpalpabler Mammaläsionen am Magnetom Open bei 0.2 T.

PURPOSE: To answer the following questions: whether reliable detection of lesions is possible in low-field-MRI-system (Magnetom Open 0.2 T) equipped with currently available hard- and software components in comparison to high field system (Magnetom Impact 1.0 T). Furthermore, whether localization of lesions suspect in MR-mammography can be realized in MR system of low field (Magnetom Open 0.2 T). PATIENTS AND METHODS: In 11 patients, suspect lesions were diagnosed in diagnostic MR-mammography acquired with high field system (Magnetom Impact 1.0 T) and were compared to low field MR-mammographies of 0.2 T (Magnetom Open 0.2 T). In six of the 11 patients a suspect lesion was localized using wire marking. RESULTS: All lesions considered suspect in diagnostic MR-mammography (Magnetom Impact 1.0 T) were also clearly identified in the 0.2 T system (Magnetom Open). In six cases wire marking was performed without any complications and with an accuracy of < or = 0.5 cm distance to the lesion. CONCLUSION: Although studies in the 0.2 T system clearly showed inferior SNR (34.6 vs. 83.1) and CNR (14.6 vs. 43.5) compared to studies with the high field system, all lesions considered suspect in diagnostic MR-mammography were reliably identified also in 0.2 T studies. Due to its open construction permitting permanent access to the breast and due to sufficient image quality, the Magnetom Open is suitable for interventions on the breast.