A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision.

OBJECTIVES: This study was a multicenter evaluation of the SAVI SCOUT(®) breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal. METHODS: This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT(®) reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT(®) handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology. RESULTS: SCOUT(®) reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision. CONCLUSIONS: SCOUT(®) provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.

Accuracy and value of breast ultrasound for primary imaging evaluation of symptomatic women 30-39 years of age.

OBJECTIVE: The purpose of this study was to determine the accuracy and value of breast ultrasound for primary imaging evaluation of women 30-39 years of age who present with focal breast signs or symptoms. METHODS: We identified all women 30-39 years of age who underwent imaging evaluation (ultrasound and mammography) at our institution between January 1, 2002, and August 31, 2006, for focal breast signs or symptoms. Each area of concern was designated a study case. Benign versus malignant outcomes were determined by biopsy or imaging surveillance and through linkage with a tumor registry with a minimum 24-month follow-up. Overall cancer yield, sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of ultrasound and mammography were calculated. RESULTS: We identified 1208 cases in 954 patients. Outcomes were benign in 1185 of 1208 (98.1%) and malignant in 23 of 1208 (1.9%) cases. Sensitivities for ultrasound and mammography were 95.7% and 60.9%, respectively. Specificities for ultrasound and mammography were 89.2% and 94.4%, respectively. NPV was 99.9% for ultrasound and 99.2% for mammography. PPV was 13.2% for ultrasound and 18.4% for mammography. Mammography detected one additional malignancy in an asymptomatic area in a 32-year-old woman who was subsequently found to have a BRCA2 gene mutation. CONCLUSION: Breast imaging is warranted in women 30-39 years of age with focal signs or symptoms because of the small (1.9%) but real risk of malignancy. Ultrasound has high sensitivity (95.7%) and high NPV (99.9%) in this setting and should be the primary imaging modality of choice. The added value of adjunct mammography is low.