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Preoperative Localization of Infraclinical Breast Tumors: Isotopic Localization by iodine125 Seed Versus Standard Localization Using a Metal Wire

NCT02759133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-01-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Metal wire

Localization technique for breast surgery using metal wire

DEVICE

Radioactive Iodine Seed

Localization technique for breast surgery using Radioactive Iodine Seed

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    lead OTHER

Principal Investigators

  • Emmanuel BARRANGER, phd · Centre Antoine Lacassagne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2022-08-03
Completion
2023-08-03

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759133 on ClinicalTrials.gov