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.     

Two-year follow-up of stereotactically guided 9-G breast biopsy: a multicenter evaluation of a self-contained vacuum-assisted device

PurposeTo evaluate the performance of a self-contained, battery-driven, vacuum-assisted breast biopsy (VABB) system for the sampling of clustered breast microcalcifications and masses under stereotactic guidance.Methods and materialsA total of 144 patients (median age: 56 years; range: 21–87 years) in four European breast centers underwent percutaneous 9-gauge (G), stereotactic-guided VABB. The median lesion size was 11 mm (range 2–60 mm). Patients were biopsied in the prone (n=125) or upright position (n=19). All patients were followed up for at least 24 months.ResultsThe stereotactic procedure was successful in 142 (98.6%) of 144 cases, with two cases cancelled due to either severe patient motion (one case) or failure to detect faint calcifications (one case). A median of 12 specimens per procedure was obtained. In 39 cases (27.5%), the suspicious lesion could no longer be detected mammographically after the biopsy procedure. The histological diagnosis was malignancy in 45 (31.7%) cases. One case of atypical ductal hyperplasia diagnosed preoperatively was upgraded to ductal carcinoma in situ (DCIS) at operation, giving an overall sensitivity of 97.7% for the vacuum-assisted biopsy procedure. In two cases where DCIS was diagnosed at vacuum-assisted biopsy, the malignant tissue was apparently completely removed and could no longer be found at operation. No serious complications occurred. During the follow-up period, no breast cancers appeared at the location of biopsy. Six patients dropped out during the follow-up period.ConclusionThe self-contained, vacuum-assisted biopsy device is well suited for stereotactically guided breast biopsies, having demonstrated excellent sensitivity and specificity in the preoperative workup of mammographically detected breast lesions after 2 years of follow-up.     

Magnetic resonance-guided biopsy of suspicious breast lesions with a handheld vacuum biopsy device

Purpose: To evaluate a handheld vacuum-assisted device system for magnetic resonance image (MRI)-guided breast lesion biopsy.

Material and Methods: In 32 patients, a total of 42 suspicious breast lesions (mean diameter 7.5 mm for mass lesions, 11.6 mm for non-masslike diffuse lesions) seen with MRI (no suspicious changes in breast ultrasound or mammography) were biopsied (27 lateral, 15 medial) using a 10G vacuum-assisted breast biopsy device under MR guidance. Histology of biopsy specimens was compared with final histology after surgery or follow-up in benign lesions.

Results: In all biopsies, technical success was achieved. Histology revealed 11 lesions with ductal carcinoma in situ (DCIS) or invasive cancer, three with intermediate lesions (LCIS) and 28 with benign breast lesions (adenosis, infected hematoma). In one patient with discordant results of MRI and histology, surgical excision revealed medullary cancer. In the follow-up (mean 18 months) of the histological benign lesions, no breast cancer development was observed. Besides minor complications (hematoma, n = 6), with no further therapeutic interventions, no complications occurred.

Conclusion: MRI-guided breast lesion biopsy using a handheld vacuum-assisted device is a safe and effective method for the work-up of suspicious lesions seen with breast MRI without changes in mammography or ultrasound. In the case of discordant histology of vacuum biopsy and breast MRI appearance, surgical excision is recommended.     

Ultrasound-guided breast biopsy using a 10-gauge self-contained vacuum-assisted device

The purpose of this study was to evaluate the diagnostic value of a self-contained battery-driven vacuum-assisted breast biopsy (VABB) system for the sampling of breast masses under ultrasound guidance. Sixty-five patients with 70 lesions underwent percutaneous 10-gauge ultrasound-guided VABB using the coaxial technique. In 38 lesions, subsequent surgery and comparison of histology was performed. The remaining 32 cases were followed-up and defined as true negative after a cancer-free interval of 24 months. VABB revealed malignant histology in 28 (40%) cases. Twenty-four malignancies were confirmed after surgery. Four invasive cancers verified in VABB were not found during surgery because they were completely removed, as proved by a disease-free interval of 24 months. One cancer missed in ultrasound-guided VABB due to its small size was successfully diagnosed with stereotactic VABB and thus turned out to be false negative, resulting in an overall sensitivity of 96.6%. Forty-one patients were free of cancer during the follow-up period of at least 24 months. In conclusion, the self-contained VABB device is well suited for ultrasound-guided breast biopsies.     

Ghost imaging for targeting breast masses with MR imaging: a phantom study

RATIONALE AND OBJECTIVES: The purpose of this study was to test the accuracy of ghost magnetic resonance (MR) imaging for guiding core biopsies of simulated breast masses in a tissue phantom. MATERIALS AND METHODS: A tissue MR phantom implanted with 20 grapes as targets was placed into an interventional breast MR coil. The locations of the centers of the targets were determined, recorded, and saved as ghost images. A nonmagnetic phantom needle was constructed to avoid imprecision secondary to magnetic field inhomogeneity and was used to determine the three-dimensional location of the needle tip in the center of each grape on the ghost image. Once the positions were determined, the true needle was placed and biopsy specimens were taken. The needle was inspected for the presence of pulp after each pass. Each grape was inspected to determine the location of the needle track in relation to the center of the grape. The duration of the procedure was recorded. RESULTS: All grapes were hit by the biopsy needle, as demonstrated either by pulp within the needle or by a needle track within the grape. Seventeen of the 20 grapes (85%) were hit centrally. Three were sampled eccentrically, up to 5-6 mm from the center. Each biopsy took approximately 1 hour. CONCLUSION: These results suggest that ghost imaging may be ideal for needle guidance in core biopsy or preoperative localization, as it extends the period of visibility after a bolus injection of contrast material. Additionally, using a phantom needle for localization appears to overcome imprecision due to magnetic field inhomogeneity of the needle.     

Interventional MRI of the breast: lesion localisation and biopsy

With the growing use of breast MRI an increasing need exists for reliable MR-guided preoperative localisation or even MR-guided needle biopsy. In this article an overview is given of the different approaches and the present state of the art. With closed magnets the following approaches have been made: freehand localisation (similar to CT-guided freehand localisation), and freehand localisation combined with a frameless stereotaxic system operating with support by ultrasound. One localisation device for supine localisation and a thermoplastic mesh for breast stabilisation have been reported. Most investigators have used compression devices to immobilise the breast and prevent shift during needle insertion. Thus far, one immobilisation and aiming device has been designed for open magnets. A small number of experiences exist with interventions on open MR units using a navigation system. Wire localisations are presently a well-established procedure. Magnetic-resonance-guided needle biopsy has been accomplished in closed systems as well as by the use of breast immobilisation devices. However, problems still exist due to severe needle artefacts, tissue shift during the intervention and fast equalisation of contrast enhancement in lesions with surrounding tissue. Therefore, needle biopsy is not recommended for lesions < 10 mm. Magnetic-resonance-guided vacuum biopsy is somewhat more invasive but promises to solve most of these problems.     

Stereotactic and ultrasound-guided breast biopsy

Percutaneous imaging-guided needle biopsy has increasingly become an alternative to surgical biopsy for the histologic assessment of breast lesions. Percutaneous biopsy is faster, less invasive, and less expensive than surgical biopsy. Tissue acquisition is performed with automated core needles or directional vacuum-assisted biopsy probes. Guidance for percutaneous biopsy is usually provided by stereotaxis, ultrasound, and, more recently, under the guidance of MR imaging. Imaging guidance depends on lesion type and the results of diagnostic imaging studies. This article reviews indications, advantages, limitations, and controversial issues in percutaneous imaging-guided biopsy of breast lesions under stereotactic and ultrasound guidance. The potential for new research opportunities and directions is also discussed.     

Percutaneous core biopsy of the breast: correlates of anxiety

RATIONALE AND OBJECTIVES: The authors performed this study to investigate the level of patient anxiety immediately preceding breast biopsy and examined potential clinical and demographic correlates of anxiety. MATERIALS AND METHODS: The authors evaluated 102 women who were referred to a radiology breast clinic to undergo breast biopsy. The women were assessed with a self-report of demographic and medical items and the State Trait Anxiety Inventory (STAI) immediately before their biopsy. The STAI also was administered at 1 and 5 days after biopsy. RESULTS: The participants' mean state anxiety T score as measured with the State Trait Anxiety Inventory was 71.1 (standard deviation, 7.2). Multiple regression analysis was performed to determine the correlates of state anxiety. The variables that showed the strongest correlation with state anxiety were trait anxiety, being concerned about the results of biopsy, education (less education was associated with more anxiety), age (an older age was associated with more anxiety), and number of relatives with breast cancer. Given the expected overlap (r = 0.55) between state and trait anxiety, a second regression analysis was performed that controlled for trait anxiety. The results of this analysis also identified age, being concerned about the results of the biopsy. and number of relatives with breast cancer as relevant correlates of state anxiety. CONCLUSION: Overall, the results give some indication of the characteristics of women likely to be most anxious before biopsy. Future research should assess the effectiveness of different strategies for addressing situational anxiety.     

An apparatus for MR-guided breast lesion localization and core biopsy: design and preliminary results

System design and initial results are presented from a new unilateral MR-guided breast lesion localization and core biopsy system. Over 150 imaging studies, an accuracy study on phantoms with 50 localization wire deployments and 33 core biopsy trials, and 19 clinical procedures are reported. The mean spatial accuracy from the lesion center for a 20-gauge (G) needle (N = 13) was within 1.2 +/- 1.4 mm (SD) and for a 14G biopsy (N = 4) 0.8 +/- 1.1 mm. For sampling using a 16G core through a 14G needle, the mean accuracy was 5.6 mm (N = 2). The needle guide geometry imposed a small, calculable targeting error. For phantom measurements using the 20G device, the mean geometry-induced error was 0.73 +/- 0.43 mm. However, this contribution was, on average, 42% of the mean measured 2.35 +/- 1.65 mm offset. The new device design provided an accurate and simple guidance method for localization or core biopsy of MR-visible breast lesions.     

Value of MR imaging in clinical evaluation of breast lesions

Purpose:
To evaluate the value of dynamic MR imaging as an adjunctive tool to triple diagnosis (TD) (physical examination, mammography and fine needle aspiration cytology) in diagnosing breast lesions. Material and Methods:
Ninety-three consecutive patients with 114 palpable or mammographically detected breast lesions were examined with TD and MR imaging. The MR examination was performed dynamically using a dedicated breast coil. Five diagnostic groups were defined on a scale from 1=normal, to 5 = malignant, where groups 1-3 were defined as benign and groups 4-5 as malignant. All lesions were histopathologically examined. The sensitivity and specificity were calculated for mammography alone, TD, MR and the combination of MR and TD. Results:
Histopathology revealed 32 benign and 82 malignant lesions (73 invasive and 9 cancer in situ). The sensitivity/specificity was 84%/59% for mammography, 93%/41% for TD, 94%/47% for MR and 99%/19% for TD + MR. In the 32 mammographically dense breasts, mammography/TD/MR/TD + MR had a sensitivity of 72%/94%/94%/100% and a specificity of 79%/57%/36%/29%, respectively. Conclusion:
MR imaging might be of value as an additive method to TD by increasing the sensitivity, but at the cost of decreasing specificity. Patients with mammographically dense parenchyma might have more benefit of the additive value, as the decrease in specificity in these patients was less pronounced in our study.     

Interdisciplinary consensus on the uses and technique of MR-guided vacuum-assisted breast biopsy (VAB): results of a European consensus meeting

Purpose

Quality assurance of MR-guided vacuum-assisted breast biopsy (VAB).

Method

A consensus was achieved based on the existing literature and experience of an interdisciplinary group comprising European specialists in breast imaging and VAB.

Results

Full imaging work-up must be completed according to existing standards before an indication for MR-guided VAB is established. The procedure should be reserved for lesions demonstrable by MRI alone.Acquisition of >24 cores (11-Gauge) should be routinely attempted, with the intention of sufficiently removing small lesions for accurate diagnosis.Following biopsy the patient should be re-imaged to demonstrate the biopsy site and its proximity to the lesion and hence the likely accuracy of the sampling. All patients should be discussed in a regular interdisciplinary conference and a documented consensus reached regarding patient management. Regular audit and review of all MR-guided VAB results and subsequent follow-up are recommended.

Conclusion

This consensus includes protocols for the indication, performance parameters, interdisciplinary interpretation therapeutic recommendation, documentation and follow-up of MR-guided VAB. It does not replace official recommendations for percutaneous biopsy.     

First experience with a new dedicated ultrasound system for computer-guided large-core breast biopsy

We describe a new dedicated ultrasound system for computer-guided large core breast biopsy (LCBB) and report our first clinical experience in 45 female patients. After an initial 30 biopsy procedures on a US breast phantom, LCBB using this new system was performed in 45 non-palpable surgically verified breast lesions. All biopsies were performed by the same radiologist using 14-gauge long-throw biopsy needles. Histological results following LCBB were compared with open surgical biopsy. Procedure time and any complication arising was registered in all procedures. Biopsies using this prototype were successful and yielded sufficient material in all 45 lesions. There were 23 benign and 22 malignant lesions with complete histological agreement between LCBB and open surgical biopsy in 44 of the 45 lesions. In one invasive ductal cancer the pathologist could only state high probability of malignancy but not give a definite diagnosis. Besides one case with early termination due to decreased visibility of the target lesion, no technical complications were noted. Slight vasovagal reactions were seen in 4 patients but did not alter the histological results. The average procedure time was 30+/-2.7 min. This new dedicated US system for computer-guided LCBB is an accurate and safe method for diagnosing breast lesions. Although this new system may have no major impact for US-guided LCBB experienced physicians, it might be a promising alternative for the non-skilled physician to currently available breast biopsy techniques.     

MR-guided percutaneous excisional and incisional biopsy of breast lesions

The aim of this study was the realisation and clinical application of MR-guided vacuum biopsy for percutaneous excisional and incisional biopsy of enhancing breast lesions. A breast biopsy system and procedure have been developed which allow precise and safe access to breast lesions in any location and use of vacuum biopsy (VB) under MR guidance. Fifty-one patients with 55 MR-detected lesions were examined. Verification of these diagnoses included re-excision histology of all 14 malignancies and for benign lesions retrospective correlation of histology and imaging, assessment of complete or partial removal of the enhancing area directly after VB (40 of 40 lesions) and follow-up MRI (33 of 40 lesions), which in contrast to conventional needle biopsy can be used as proof of representative removal. Fifty-four of 55 procedures (including 15 lesions ≤ 5 mm and another 26 lesions of 5–10 mm size) were successful. One failure was caused by incorrect use of the VB gun. Vacuum biopsy yielded 14 malignancies and 40 benign lesions. With the available verification techniques all diagnoses proved correct. Percutaneous VB became possible under MR guidance. With minimal invasion it allowed increased certainty and accuracy even for very small lesions. Received: 17 August 1998; Revised: 15 January 1999; Accepted: 10 February 1999     

Use of a novel percutaneous biopsy localization device: initial musculoskeletal experience

OBJECTIVE: To preliminarily evaluate a new CT-biopsy guidance device, the SeeStar (Radi, Uppsala, Sweden), for use in musculoskeletal applications. DESIGN: The device was evaluated using an imaging phantom and in various simulated clinical biopsy situations. The phantom study was undertaken to optimize the linear metallic artifacts produced by the guidance device. The phantom and guidance device were imaged with CT after altering different imaging parameters, including field of view, filter, focal spot size, kV, mAs, slice thickness and pitch. Clinical biopsy situations were simulated for a superficial biopsy, a deep biopsy and a horizontal biopsy approach. RESULTS: Altering CT parameters had little effect on the subjective appearance of the linear metal artifact, which is used to plan the biopsy approach. Placement of an 18-G needle inside of the biopsy device was subjectively helpful in exaggerating the artifact. Use of this artifact could be helpful in planning biopsy approach for deep lesions or lesions near critical structures. The metal guide on the device adequately supports a standard biopsy needle, making it potentially advantageous for biopsy of superficial lesions and lesions approached from a horizontal orientation. CONCLUSION: Use of this CT-biopsy guidance device is potentially useful for musculoskeletal applications. The linear metal artifact produced by the device can help plan the biopsy approach. The device can also be useful in biopsy situations where the biopsy needle requires external support during imaging.     

Two cases of metastases to the breast on MR mammography

We report appearance of two cases of metastases to the breast on MR mammography. Metastasis from cervical cancer displayed a hypointense tumor with a central area of high signal intensity on T2-weighted images and rapid annular enhancement with persistent central contrast enhancement. The metastases from rhabdomyosarcoma were characterized by multiple tumors with high signal intensity on T2-weighted images and fast annular contrast enhancement. We show unusual malignant breast lesions for possible identification in dynamic MR mammography. Received: 21 March 2000 Revised: 13 July 2000 Accepted: 19 July 2000     

Initial clinical experience with a new MRI vacuum-assisted breast biopsy device

PURPOSE: To report initial clinical experience with a new previously unreported vacuum-assisted device (EnCor MR, SenoRx, Aliso Viejo, CA) for magnetic resonance imaging (MRI)-guided breast biopsy and to compare this device with previously reported technologies. MATERIALS AND METHODS: A prospective study of MRI-guided vacuum-assisted breast biopsies using the EnCor device was undertaken. Lesions targeted for biopsy were occult on mammography, ultrasound, and physical examination. Histologic results were obtained for all cases. Patients with benign, concordant results underwent clinical and imaging follow-up. Cases with discordant, high-risk, or malignant results were referred for surgical biopsy. RESULTS: A total of 55 biopsies were performed in 47 patients. All biopsies were technically successful. Histologic results yielded malignancy in 10 (10/55, 18%) of the 55 lesions and high-risk or atypical lesions in 7 (7/55, 13%) of the cases. All of these patients have had surgical follow-up, with four (4/55, 7%) underestimations. There were three (3/55, 5%) discordant cases. 35 (35/55, 64%) lesions yielded benign concordant results. Of these, six (6/35, 17%) lesions were removed surgically, with confirmation of the MR-guided biopsy results. Twenty (20/35, 57%) lesions have undergone at least 6-month follow-up MRI, with resolution or stability of the MRI findings. CONCLUSION: The EnCor breast biopsy device has comparable results to those previously reported for other MRI-guided vacuum-assisted technologies.     

Belt device for simplified CT-guided puncture and biopsy: A technical note

A new radiolucent device for increased accuracy of CT-guided fine-needle punctures permits precise determination of the optimum angle, depth, and position of the fine needle, which can be preset from the data supplied on the CT monitor. Puncture and repeat scans for controlling the tip of the needle can be performed with the patient in a stationary position. The device is designed as a belt that holds a needle holder sheath and a goniometric scale, both of which can be moved to varying positions around the patient.