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

Breast Neoplasms Clinical Trial

— FLUOTECH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279108
• Other study ID #: 1408153
• Secondary ID: 2014-004005-32
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2014
• Last updated: September 5, 2017
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• indocyanine green
One injection, 2.5 milligrams per patient, intradermal use
• isotope
One injection, 20 MBq techntium99, intradermal use

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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