NCT02759133

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2023

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

6.2 years

First QC Date

April 19, 2016

Last Update Submit

January 28, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • comparison of the rates of incomplete resection of the tumorectomy specimen defined according to the recommendations of the American Society of Breast Surgeons

    up to 24 months

Secondary Outcomes (3)

  • surgical revision rate

    up to 24 months

  • Visual Analog Score for pain

    up to 24 months

  • Duration of surgical procedures

    up to 24 months

Study Arms (2)

A - A standard Localization technique

ACTIVE COMPARATOR

A standard Localization technique : Metal wire as localization technique for breast cancer surgery

Device: Metal wire

B - Experimental Localization technique

EXPERIMENTAL

Experimental Localization technique: Radioactive Iodine seed as localization technique for breast cancer surgery

Device: Radioactive Iodine Seed

Interventions

Metal wireDEVICE

Localization technique for breast surgery using metal wire

Also known as: standard Localization technique
A - A standard Localization technique
Radioactive Iodine SeedDEVICE

Localization technique for breast surgery using Radioactive Iodine Seed

Also known as: Experimental Localization technique
B - Experimental Localization technique

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 or over
  • Patients suffering from unifocal or in situ invasive or ductal breast cancer proven by anatomopathologic analysis (biopsy).
  • Non-palpable tumor measuring at least 5 mm (minimum size deemed sufficient for the lesion to be visible by ultrasound) and ≤ 30 mm, visible by ultrasound and constituting a mass.
  • Patients needing conservative first surgery management by preoperative tumor localization. For women of childbearing age, an effective contraceptive is mandatory throughout the study and up to 6 months post-operatively.
  • Patients who have been made aware of the information sheet and have given their written signed informed consent.
  • Patients benefitting from social health insurance coverage.

You may not qualify if:

  • Patients with a history of homolateral breast cancer.
  • Patients who have undergone neoadjuvant chemotherapy.
  • Multifocal or multicentric cancer.
  • Metastatic breast cancer.
  • Cancer presenting in the form of microcalcifications with no visible mass.
  • Vulnerable patients: pregnant or breastfeeding women, women deprived of their freedom by administrative or judicial decree, adults subject to a legal protection order or unable to give their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Antoine LACASSAGNE

Nice, 06000, France

Location

Related Publications (1)

  • Barranger E, Najib B, Dejean C, Jacquinot F, Chateau Y, Chamming's F, Weitbruch D, Gosset M, Delpech Y, Gal J. Iodine125 grain isotope detection compared to standard metal guide detection for breast cancers: The IODINE BREAST, a randomised, non-inferiority trial. Eur J Surg Oncol. 2026 Feb;52(2):111376. doi: 10.1016/j.ejso.2025.111376. Epub 2025 Dec 29.

    PMID: 41477927RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Emmanuel BARRANGER, phd

    Centre Antoine Lacassagne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 3, 2016

Study Start

June 1, 2016

Primary Completion

August 3, 2022

Study Completion

August 3, 2023

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)