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Radioguided Occult Lesion Localisation by Indocyanine Green

NCT03313908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

PROCEDURE

detection of the tumor lesion

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Gauthier GR RATHAT, MD · Montpellier Univerity Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2018-07-19
Completion
2018-12-19

Countries

  • France

Study Locations

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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 NCT03313908 on ClinicalTrials.gov