A Multi-site Validation Trial of Radioactive Seed Localization as an Alternative to Wire Localization

Abstract

This study aims to validate radioactive seed localization (RSL) as an alternative to wire localization (WL) in the operative excision of nonpalpable breast lesions. Eligible patients were recruited sequentially. A sample of 99 patients treated with WL was compared to the next 383 patients treated with RSL. Margins were considered "negative" if > or =2 mm from in-situ and invasive disease. Pain and convenience scores were recorded on a 10-point scale. Patient characteristics and histology were similar. The lesion and localization device were retrieved in all patients. Margins of the first specimen were negative in 73% of RSL patients, versus 54% of WL patients (p < 0.001). A second operation was required in 8% of RSL patients to achieve negative margins, versus 25% of WL patients (p < 0.001). Pain scores were not statistically different. However, the RSL group had higher convenience scores (p = 0.015). RSL is safe, effective, and compared to WL, reduces the rates of intraoperative re-excision and reoperation for positive margins by 68%. Patient satisfaction is improved with RSL. We strongly favor RSL over WL.

Identification of residual breast tumour localization after neo-adjuvant chemotherapy using a radioactive 125 Iodine seed

“…The rate of positive margins in our study was 6%, which is at least comparable to the 8% rate reported by Gray et al (14)(15)(16)(17) and is well below the rate of 50,9% for excisions utilizing wire localization that was reported by Velanovic et al (29), both studies in non-palpable breast tumours. In a another prospective randomized trial of radioactive seed localization versus wire localization of non-palpable breast lesions, Hughes et al (30) found that radioactive seed localization resulted in a 35% relative improvement in the rate of negative margins in the first specimen and a 62% relative improvement in the rate of re-operation for positive margins.…”

“…Radioactive seed localisation was carried out as described by Gray et al (14)(15)(16)) using a titanium seed containing 7 Mbq of Iodine-125 ( 125 I). This radio nuclide has a half-life of 60 days and is a 27 keV source of gamma radiation.…”

“…Implantation -using standard image guided techniques -of a single 125 Iodine ( 125 I) labelled titanium seed before the chemotherapy into the tumour bed puts up with these prerequisites. (15)(16) The 125 Iodine ( 125 I) labelled titanium seed has been described for the localisation of non palpable breast tumours. (14)(15)(16)(17).…”

“…(15)(16) The 125 Iodine ( 125 I) labelled titanium seed has been described for the localisation of non palpable breast tumours. (14)(15)(16)(17). We used the 125 I seed to mark the tumour bed in patients who were planned to receive neo-adjuvant chemotherapy for breast M A N U S C R I P T…”

ROLL versus RSL: toss of a coin?

“…Great variation exists in the radiation dose administered for ROLL, with the literature quoting anywhere between 5 and 123 MBq, [12,13] whilst for RSL it is between 3.7 and 10.7 MBq [14,15]. ROLL requires localization to be performed within 24 h of surgery due to the short 6 h half-life of 99m Tc-labelled colloid and RSL typically is performed 0-5 days prior to surgery [7,[14][15][16][17].…”