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This is a monocentric, non-inferiority, randomized cohort study with an open 1:1 ratio comparing the impact of iodine seed tumor localization (arm B) vs. standard localization using a metal guide (arm A) on the quality of the surgical resection margins in parallel groups with an interim analysis in patients with breast cancer.
Randomization will be performed using histologic status stratification: in situ ductal /invasive lobular +/- an in situ component / invasive ductal +/- an in situ component.
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The widespread development of organized breast cancer screening has enabled diagnosis of nonpalpable, small-size cancer lesions (infraclinical stage). When conservative breast surgery is scheduled (tumorectomy or zonectomy), preoperative localization of the lesion is mandatory. To date, wire localization of non-palpable lesions is the most frequently used technique worldwide.
Nevertheless, this technique presents a number of drawbacks:
This technique appears to offer several advantages:
Furthermore, various studies have demonstrated the safety of this technique in terms of radiation protection as radiation is minimal to the patient (equivalent to the amount received from two mammography views) as well as to the staff. Its reliability regarding the surgical excision procedure (positive or inadequate margin rates, revision surgery rates) has been demonstrated in 3 randomized studies with a high level of evidence.
Thus, in 2001, Gray et al. published the first randomized study comparing the RSL technique with the conventional wire method and showed the superiority of iodine seed localization in terms of positive margin and surgical revision rates (RSL 26% vs WL 26%, p=0.02) with no concomitant increase in tumorectomy specimen volumes or marker migration rates. More recently, Lovrics et al. (2011) and Bloomquist et al (2015) published randomized non-inferiority studies highlighting the equivalent results between these two techniques regarding the quality of tumor excision (positive margins rates in: RSL 15.1% vs WL 19% p=0.389, and in: RSL 19.4% vs 15.3%, p=0.53). In addition, the RSL method showed a significant advantage regarding operating times and pain experienced by patients during the localization procedure.
No French team has investigated this localization method on account of legal constraints. Nonetheless, it would appear that the wire localization technique does not satisfy surgical teams since another pre-operative localization technique involving injection of Tc99m into contact with the tumor has been developed over the past few years to replace the wire method. This procedure has met with little success, and has been gradually abandoned. Unfortunately, injecting Tc99m around the tumor renders the surgical procedure less precise or necessitates resecting a large segment of the gland with potentially damaging esthetic repercussions. Implantation of a sealed radioactive source such as an iodine seed helps mitigate this drawback.
This study project aims to evaluate the feasibility and safety of using 1 grain of iodine for localization purposes by means of a randomized comparative study comparing wire localization with iodine seed localization in patients presenting an in situ, biopsy-proven, non-palpable invasive or ductal breast carcinoma requiring conservative surgical management associated, or not, with an axillary procedure (SN removal or axillary curettage).
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350 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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