Clinical trial NCT02279108: Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Official title: Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: sentinel lymph node
indocyanine green
fluorescence method
radioisotope conventional method
breast cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Patients With Less Than Two Lymph Nodes Detected
timeFrame: peroperative
Secondary outcomes:
measure: Number of Lymph Nodes ICG Positive and Tc Positive
timeFrame: Peroperative
measure: Number of Lymph Nodes ICG Positive and Tc Negative
timeFrame: Peroperative
measure: Number of Lymph Nodes ICG Negative and Tc Positive
timeFrame: Peroperative
measure: Comparison Between Groups of the Time of the Surgery
timeFrame: Peroperative
measure: Comparison Between Groups of Anesthesia Time
timeFrame: Peroperative
measure: Time From Injection of One Dose ICG Injection to Incision Time
timeFrame: Peroperative
measure: Comparison Between Groups of Time Surgery Node
timeFrame: Peroperative
measure: Number of Patients With ICG Allergy
timeFrame: peroperative
measure: Number of Patients With ICG Allergy
timeFrame: 1 hour after the end of the surgery
measure: Number of Patients With ICG Allergy
timeFrame: Month 2
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Céline CHAULEUR, PhD
role: PRINCIPAL_INVESTIGATOR
References: