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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: indocyanine green; Drug: isotope

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Étienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: double detection Indocyanine + isotope; intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery	Drug: indocyanine green; One injection, 2.5 milligrams per patient, intradermal use; Drug: isotope; One injection, 20 MBq techntium99, intradermal use; Other Names: technetium
Active Comparator: isotope detection alone; intradermal injection of 20 MBq of technetium 99 before breast surgery	Drug: isotope; One injection, 20 MBq techntium99, intradermal use; Other Names: technetium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Less Than Two Lymph Nodes Detected	Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone	peroperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lymph Nodes ICG Positive and Tc Positive	Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive	Peroperative
Number of Lymph Nodes ICG Positive and Tc Negative	Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative	Peroperative
Number of Lymph Nodes ICG Negative and Tc Positive	Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive	Peroperative
Comparison Between Groups of the Time of the Surgery	time from incision to wound closure	Peroperative
Comparison Between Groups of Anesthesia Time	time from the injection of anesthesic to the waking	Peroperative
Time From Injection of One Dose ICG Injection to Incision Time	time from injection of one dose ICG injection to incision time	Peroperative
Comparison Between Groups of Time Surgery Node	time from incision time to the last node surgery	Peroperative
Number of Patients With ICG Allergy	allergy is : redness, edema, itching, larynges edema and/or allergic shock	peroperative
Number of Patients With ICG Allergy	allergy is : redness, edema, itching, larynges edema and/or allergic shock	1 hour after the end of the surgery
Number of Patients With ICG Allergy	allergy is : redness, edema, itching, larynges edema and/or allergic shock	Month 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Céline CHAULEUR, PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; sentinel lymph node; indocyanine green; fluorescence method; radioisotope conventional method
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1408153; 2014-004005-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No