Prospective Randomized Trial of Use of In‐House Prepared Low‐Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer

Abstract

In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, Tc-antimony colloid and commercially marketedTc-sulphur colloid as radiopharmaceutical, while Tc-antimony colloid was much cheaper thanTc-sulphur colloid.

Low‐cost Fluorescein as an Alternative to Radio‐colloid for Sentinel Lymph Node Biopsy—a Prospective Validation Study in Early Breast Cancer

“…Meta-analyses and other studies have, however, refuted these findings, as MBD alone was found to have unacceptably high FNR [5,18]. We demonstrated that low-cost in-house-produced radioactive antimony colloid in combination with MBD was a cheaper and equally efficacious alternative to the commercially available radioactive Sulfur-colloid in a randomized study [17,25]. The radioactive antimony is a low-cost alternative in centers having nuclear medicine facilities.…”

“…Exclusions were as follows: pregnancy, prior chemotherapy, surgery or radiation to, or scarring of breast or axilla, multiple tumors, allergy to any tracers, and refusal to undergo a validation axillary clearance. Patients were planned for either a breast conserving surgery or a mastectomy along with validation SLNB for axilla as previously described by us [16, 17]. In validation SLNB, we performed SLNB followed by removing “rest of axillary tissue.” Site of injection for all three dyes was half sub‐areolar and half peri‐tumoral in breast parenchyma.…”