Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer (FLUOTECH)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: isotope; Drug: indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02279108

1408153

2014-004005-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

double detection Indocyanine + isotope

Experimental group

Description:

intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery

Treatment:

Drug: indocyanine green

Drug: isotope

isotope detection alone

Active Comparator group

Description:

intradermal injection of 20 MBq of technetium 99 before breast surgery

Treatment:

Drug: isotope