Background: Management of clinically occult breast lesions is still a major point of debate. Several techniques (eg, skin projection, guidewire localization) have been proposed, but all of them have technical limitations. Study Design: The aim of this study was to assess the efficacy of a new method to locate occult breast lesions using technetium-99m ( 99mTc)- labeled colloid particles of human serum albumin (radioguided occult lesion localization). We studied 647 consecutive patients (mean age 51.3 years; range 25 to 77 years) with nonpalpable breast lesions detected mammographically or by ultrasonography. Within 24 hours before operation, 3.7 MBq (0.1 mCi) of 99mTc-labeled colloid was injected directly into the center of the lesion using stereotactic mammographic guidance (when only microcalcifications were present) or ultrasonographic guidance (for opacities). Excision biopsy was performed with a gamma-detecting probe. After excision, the area was checked for residual radioactivity and the specimen was radiographed to verify complete removal of the lesion. The material was then sent for pathologic examination. The absorbed dose to the inoculated area and the external irradiation to staff were also determined. Results: In all 647 patients, the 'hot spot' was located easily and quickly. X-ray and scintigraphy of the specimen verified the presence and centricity of the lesion in all patients but three (99.5%). Pathologic examination revealed 340 cancer lesions (52.6%). Of these patients, 339 (99.7%) were treated by breast-conserving operations and one (0.3%) received a modified radical mastectomy. No major surgical or postoperative complications were encountered. No recurrences were documented during follow-up. The absorbed dose to the breast and other tissue was negligible (0.03 ± 0.02 mGy/MBq), as was the dose to the surgeon's hands (7.5 ± 5.0 μSv/h). The latter dose represents 0.015% and 0.002% of the recommended limits of the European Community for the general population and for exposed workers, respectively. Conclusions: Radioguided occult lesion localization seems to offer a simple and reliable method to locate occult breast lesions with a gamma-detecting probe, allowing complete removal of the lesion in 99.5% of patients. Because of the small quantity of radioactivity, the procedure is safe for both patients and medical staff. (C) 2000 American College of Surgeons.
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