[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.

[3D ultrasound (3D US) in the diagnosis of focal breast lesions]. / 3D-Ultraschall (3D-US) in der Diagnostik von Mammaherdbefunden.

BACKGROUND: It was to analyse whether 3D breast US is able to enhance the diagnosis of focal breast lesions. MATERIAL AND METHODS: 60 patients were examined with 2D- and 3D US (GE logiq 9, 14 MHz). The solid lesions were analyzed by using the BIRADS classification. As standard of reference, histopathologic results were available in all cases. RESULTS: 38 malignant and 22 benign lesions were analyzed. With 2D US the sensitivity/specificity was 92/81%, with 3D US 97/72%, and by combination of 2D and 3D 97/81%. Characteristics of benign solid masses included a round or oval shape as well as clearly defined and sharply demarcated margins. CONCLUSIONS: 3D US allows to demonstrate breast masses in multiple planes. Distorsion of the surrounding soft tissues is an important sign indicative of malignancy.

[O-twist marker for post-interventional marking in imaging of suspected breast lesions]. / O-Twist-Marker zur postinterventionellen Markierung in der Bildgebung suspekter Mammaläsionen.

AIM: The aim of this study was to develop a marker clip for use in minimally invasive diagnostics of breast cancer that can be placed and visualized during ultrasonography, mammography, and magnetic resonance imaging. METHODS: The newly developed O-twist marker consists of three 0.15-mm biocompatible nitinol wires twisted together to form rings with a diameter of 2.5 mm. These are inserted elongated into a 20G cannula. The marker is ejected into the tissue through a mandrin and reverts to its predetermined ring form. RESULTS: The multiple curves of the surface render the marker highly visible. Its geometry permits secure anchorage even in larger biopsy cavities and additionally prevents migration within the tissue. CONCLUSION: The O-twist marker is applicable for all examination modalities and biopsy needles or biopsy systems and represents an important development for breast cancer diagnostics.

[Sonographically guided, minimally invasive biopsy of uncertain mammary lesions. Clinical experience with a new biopsy system]. / Sonographisch gesteuerte minimalinvasive Biopsie unklarer Mammaläsionen Klinische Erfahrungen mit einem neuartigen Biopsiesystem.

METHODS: We performed Vacora biopsy on 53 patients for minimally invasive breast diagnostics. Each histologically malignant lesion underwent surgery. The histopathology of the Vacora biopsy was then compared to the surgical report. When there was a discrepancy between Vacora histopathology and the report, the patient underwent open biopsy. In all patients with benign histopathology results, sonography was performed 5-7 days after biopsy and after 3 months. RESULTS: We performed biopsies on two lesions in eight patients, and on three lesions in one patient. Mean age of the patients was 52.1+/-12.8 years. A total of 62 lesions were examined. Mean size of the lesions was 13.3+/-9.6 mm. Fourteen (26.4%) were malignant (n=2 DCIS, n=12 invasive carcinoma). Histological grading was identical for Vacora biopsy and the surgical specimens. One case showed ADH by Vacora biopsy, which was confirmed by open biopsy. Vacora biopsy generated one false negative. There were a total of 36 benign lesions. CONCLUSION: Vacora biopsy under sonographic guidance is a method which is easy to handle, diagnostically accurate and without severe complications. Due to higher costs in comparison to high speed core biopsy, Vacora biopsy should be performed only in cases in which high speed core biopsy is not expected to result in a valid result.

[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.

Reduction mammaplasty in granular cell tumour of the breast.

Granular cell tumour of the breast is a rare peripheral nerve tumour. A case in a 34-year-old woman is reported. The clinical and histological differentiation from invasive malignant neoplasm and the surgical management are discussed. Core needle biopsy preoperatively is able to establish the definite diagnosis and help to avoid surgical overtreatment.

[Minimally invasive biopsy and preoperative marking of suspect mammary lesions]. / Minimal-invasive Biopsie und präoperative Markierung suspekter Mammaläsionen.

Image-guided minimally invasive needle biopsy is an established method in the diagnosis of breast cancer, which - when indicated correctly and carried out with quality control - equals or even surpasses open diagnostic surgery. Therefore, an open diagnostic biopsy should only be performed as well-founded exception. Depending on the visibility in the various diagnostic techniques of the condition to be clarified histologically, needle biopsy has to be carried out with the image-guided procedure which can identify the mammary lesion most reliably. If a lesion is detectable mammographically as well as sonographically, a high-speed large-core biopsy is preferred, taking the strain on the patient and the costs into account, too. In the case of suspect microcalcifications, the needle biopsy has to be controlled stereotactically. Here, vacuum-assisted procedures [Mammotome, VacuFlash (BIP)/Vacora (Bard)] yield markedly better results when compared with large-core biopsy and are also preferred for lesions which are only visible on magnetic resonance tomography. Without exception, preoperative wire marking should be used in cases of suspect nonpalpable lesions in imaging diagnostics or even more so of lesions which have already been classified histologically as malignant by minimally invasive procedures before surgery. This is the only way to safely find the suspect and nonpalpable lesion during the operation and to excise it with a sufficient safety margin while preserving as much healthy issue as possible. Quality-controlled diagnostics and therapy of breast cancer constitute an interdisciplinary challenge and yield optimal results only when all concerned specialties collaborate in the best possible way.

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.

[Screening lowers breast cancer mortality. Motivate your patients for mammography]. / Screening senkt Brustkrebs-Sterblichkeit. Motivieren Sie Ihre Patientinnen zur Mammographie.

Breast cancer is the most common malignant disease in women under 70, and the most common cause of death in those under 50. Causal prophylaxis is unknown. Only early diagnosis prior to the onset of lymphogenic or hematogenic metastasization improves the prognosis. Since the early nineteen-sixties, large-scale studies have shown that screening mammography can reduce mortality. Furthermore, early diagnosis enables breast-conserving treatment in up to 70% of cases. Disadvantages of screening mammography currently under discussion are the radiation burden, the number of false-positive diagnoses prompting biopsy and incurring costs. In Germany, the cost of screening mammography in women with no relevant history or clinical symptoms is not borne by the state-affiliated health insurance carriers. Currently, ongoing pilot projects are investigating quality-controlled early diagnosis with mammography.

[Time needs in evaluating digital thoracic images on the monitor in comparison with alternator]. / Zeitbedarf bei der Befundung digitaler Thoraxaufnahmen am Monitor im Vergleich zum Alternator.

PURPOSE: Evaluation of time efficiency in softcopy reading versus hardcopy reading of digital chest x-rays. MATERIAL AND METHODS: 130 normal and pathologic chest x-rays in two plains were analyzed by 4 experienced radiologist at both a digital workstation and the light box. Reading time and switch time between two patient folders were measured as well as the frequency of post-processing at the monitor. RESULTS: Reading time at the workstation slightly exceeded reading time at the light box; differences were not statistically significant. Post-processing (frequency between 2% and 83%) did not significantly prolong reading time. Mean switch time between two patient folders was 4.3 sec at the workstation and 13.7 sec at the light box. CONCLUSION: As compared to hardcopy reading, softcopy reading of digital chest x-rays does not significantly increase reading time. Switch time between patient folders can be reduced at the workstation by a factor of two to four.

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.

Differentiation of malignant from benign solitary pulmonary lesions using chest radiography, spiral CT and HRCT.

OBJECTIVE: The aim of this prospective study was to summarize all of the qualitative and quantitative imaging criteria for the differentiation of solitary pulmonary lesions (SPLs) as malignant (MSPLs) or benign (BSPLs) described in the literature and to critically analyze the different characteristics in order to evaluate their clinical importance and usefulness as criteria for a discrimination during the primary diagnostic assessment of SPLs using chest radiography, spiral computed tomography (SCT) and high-resolution computed tomography (HRCT). MATERIALS AND METHODS: SPLs were examined, evaluated and then completely removed by surgery in 104 consecutive patients (MSPLs n=81, BSPLs n=23). No SPL was excluded by size. Chest radiography was performed with frontal and lateral views, SCT was carried out with a slice thickness of 8 mm and HRCT with a slice thickness of 1 mm and a 12-cm field of view. RESULTS: All the characteristics which enabled a reliable differentiation of MSPLs from BSPLs were characteristics which were observed significantly more frequently in MSPLs than BSPLs. Useful characteristics for the differentiation of MSPLs from BSPLs (1) using chest radiography were the indistinct edge (P<0.0001) and a ground-glass opacity of the lung parenchyma adjacent to the SPL (P<0. 05); (2) using SCT the presence of spicules (P<0.0005), the vessel sign (P<0.0005), necrotic areas (P<0.001), spicules extending to the visceral pleura (P<0.005), circumscribed pleural thickening (P<0. 005), inhomogeneity (P<0.01), a ground-glass opacity of the lung parenchyma adjacent to the SPL (P<0.01), the lesion density (P<0.05), pleural retraction (P<0.05) and the bronchus sign (P<0.05); and (3) using HRCT the presence of spicules (P<0.00005), spicules extending to the visceral pleura (P<0.0005), the vessel sign (P<0.0005), pleural retraction (P<0.001), circumscribed pleural thickening (P<0. 001), the bronchus sign (P<0.005), a ground-glass opacity of the lung parenchyma adjacent to the SPL (P<0.01), the lesion density (P<0.05) and the length of spicules (P<0.05). Using any one of the characteristics with a significance level of P<0.01, the identification of MSPLs (1) using chest radiography showed a sensitivity of 64.2% and a specificity of 82.6% (accuracy of 68.3%); (2) using SCT a sensitivity of 88.9% and a specificity of 60.9% (accuracy of 82.7%); and (3) using HRCT a sensitivity of 91.4% and a specificity of 56.5% (accuracy of 83.7%). CONCLUSIONS: Using chest radiography, SCT and HRCT, a precise morphological assessment of the periphery of the pulmonary lesion and the adjacent visceral pleura is necessary to distinguish MSPLs from BSPLs. In this respect SCT and HRCT are useful in differentiation of MSPLs from BSPLs. However, metastases strongly resembled benign lesions in terms of size and edge type and chronic inflammatory pseudotumors as a group mimic MSPLs.

Liver intraarterial chemotherapy: use of the femoral artery for percutaneous implantation of catheter-port systems.

To provide intraarterial chemotherapy of the liver in 30 outpatients with colorectal cancer metastases and other malignancies, 32 catheter-port systems were implanted percutaneously via the femoral artery. Mean patency was 229 days. Percutaneous placement was feasible and safe. Compared with surgical placement, the overall complication rate (12%) was comparable or less.

[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.