Clinical trial · Interventional
Preoperative Localization of Infraclinical Breast Tumors: Isotopic Localization by iodine125 Seed Versus Standard Localization Using a Metal Wire
Preoperative Localization of Infraclinical Breast Tumors: Isotopic Localization by iodine125 Seed Versus Standard Localization Using a Metal Wire: A Randomized Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metal wire | Device | — | UNRESOLVED |
| Radioactive Iodine Seed | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A - A standard Localization technique
- description
- A standard Localization technique : Metal wire as localization technique for breast cancer surgery
- interventionNames
- Device: Metal wire
- type
- EXPERIMENTAL
- label
- B - Experimental Localization technique
- description
- Experimental Localization technique: Radioactive Iodine seed as localization technique for breast cancer surgery
- interventionNames
- Device: Radioactive Iodine Seed
Primary outcomes (1)
- measure
- comparison of the rates of incomplete resection of the tumorectomy specimen defined according to the recommendations of the American Society of Breast Surgeons
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- RESULTBarranger 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 41477927