Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy
OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy
versus needle localized breast biopsy on operative time and tissue loss in patients with
nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods
in these patients. III. Demonstrate that radioactive seed localization allows for
elimination of specimen x-ray in these patients. IV. Demonstrate that radioactive seeds may
be placed safely for 1-7 days prior to surgical removal in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two diagnostic arms.
Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or
palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the
lesion along with the seed and a small margin of surrounding breast tissue followed 3 months
later by a postoperative mammogram. Arm II: Patients undergo a needle localized breast
biopsy with a specimen x-ray.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Tissue Loss Rates for Each Arm
Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on tissue loss in patients with nonpalpable breast lesions.
Charles E. Cox, MD, FACS
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|