Completed

NCT Number: NCT03313908

Radioguided Occult Lesion Localisation by Indocyanine Green

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, 34295, France

About this study

The study is prospectively conducted during six months of 2017-2018 in the department of gynaecology of Montpellier .

This study includes ten women. Patients will receive both techniques: indocyanine green fluorescence (experimental technique) and radiocolloid (reference technique).

Inclusion will be during the preoperative consultation after checking the inclusion / non inclusion criteria and signing a written consent.

Radioactive localization with technetium will be done on surgery eve like usual. Fluorescence localization with ICG will be done in the operating room under general anesthesia by the radiologist under ultrasound.

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. Dissection and excision of the tumor using the radiocolloid probe (no modification of surgical management). At the end of the surgical procedure, verification of no residual radioactivity and no residual fluorescence. Again, 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.

The following data were recorded prospectively: demographics, medical history, localization of tumor, surgery, pathology results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

palpable tumor
multifocal tumor
antecedent of breast surgery

Treatment and study plan

detection of the tumor lesion

Procedure

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

Primary outcomes

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

Time frame: during breast surgery

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

A Feasibility Study (ROLL-I) of Indocyanine Green (ICG) Fluorescence Mapping for Non-palpable Breast Cancers

Acronym: ROLL-1

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 18, 2017
Registry last updated: Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed