Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: indocyanine green Type: Drug
Name: isotope Type: Drug
Overall Status
Recruiting
Summary
The sentinel node has a fundamental role in the management of early breast cancer.

Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.

So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.

Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)

- Unifocal or multifocal but in same quarter

- Size < 5cm clinically palpable or not

- Clinically or ultrasound axillary N0

- Isotopic sentinel node detection

- Adult patient

- Signed informed consent by patient or legally responsable authority

- Patient registered to a social security system

- No surgical contra-indication

Exclusion Criteria:

- Mammary carcinoma recurrence

- Previous same side mammary reduction

- Previous lumpectomy

- Contra-indication to surgery

- Pregnant or breast feeding patient

- Denial of participation
Location
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France
Status: Recruiting
Contact: Céline CHAULEUR, PhD - (0)477828611 - celine.chauleur@chu-st-etienne.fr
Start Date
November 2014
Completion Date
January 2016
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Source
Centre Hospitalier Universitaire de Saint Etienne
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page