Radioguided Occult Lesion Localisation by Indocyanine Green

NCT03313908 | Completed DMC

• 1 other identifier: RECHMPL17_0131
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and their small size encourage the investigators for finding methods simpler and more efficient to treat them by breast-conserving surgery with acceptable cosmetic results. The pre-operative detection of the tumor lesion is currently carried out by two methods: the radioactive seed localization and guidewire technique. Each has its disadvantages: the guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid requires a specialized and complex organization around this radioactive product. Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in breast cancer and seems promising. In this study, investigators evaluate the feasibility and performance of indocyanine green fluorescence in non-palpable tumor detection in comparison with radioactive seed localization (ROLL) Secondary objectives are evaluate the feasibility of the location by the radiologist, feasibility of detection by the surgeon, study of the product and the probe.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• difference between the area of the indocyanine green fluorescence and radioactive area

  By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal. An picture will be made of these two markers and it will be noted the distance between them. At the end of the surgical procedure, surgeon identified and marked in the excised sample the area of fluorescence and radioactive. The pathological examination of the resected specimen will describe positions of mark compared tumor.

  during breast surgery

Study Arms (1)

breast surgery

EXPERIMENTAL

during the breast surgery, detection of the tumor lesion with indocyanine green fluorescence and with radioactive seed localization, in each subject

Procedure: detection of the tumor lesion

Interventions

detection of the tumor lesion PROCEDURE

non palpable tumor detection with indocyanine green fluorescence and radioactive seed localization

breast surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman Age ≥ 18 years
• Non-palpable tumor
• Single tumor
• First breast surgery
• Histology: ductal carcinoma
• Written consent
• Being affiliated or benefiting from a French social security system

You may not qualify if:

• palpable tumor
• multifocal tumor
• antecedent of breast surgery

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Related Publications (2)

• Duraes M, Crochet P, Pages E, Grauby E, Lasch L, Rebel L, Van Meer F, Rathat G. Surgery of nonpalpable breast cancer: First step to a virtual per-operative localization? First step to virtual breast cancer localization. Breast J. 2019 Sep;25(5):874-879. doi: 10.1111/tbj.13379. Epub 2019 Jun 9.

  PMID: 31179597 RESULT

• Francini S, Rathat G, Manna F, Pages E, Rebel L, Perrochia H, Taourel P, Ranisavljevic N, Duraes M. Occult lesion localization by indocyanine green fluorescence for nonpalpable breast cancer. Breast J. 2020 May;26(5):1101-1103. doi: 10.1111/tbj.13760. Epub 2020 Jan 28. No abstract available.

  PMID: 31989733 RESULT

Study Officials

• Gauthier GR RATHAT, MD

  Montpellier Univerity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 18, 2017
• Study Start: October 17, 2017
• Primary Completion: July 19, 2018
• Study Completion: December 19, 2018
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)