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

NCT02279108 | Completed Phase 3 Results

• 2 other identifiers: 14081532014-004005-32
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

sentinel lymph node; indocyanine green; fluorescence method; radioisotope conventional method; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Lymph Nodes ICG Positive and Tc Positive

  Peroperative

• Number of Lymph Nodes ICG Positive and Tc Negative

  Peroperative

• Number of Lymph Nodes ICG Negative and Tc Positive

  Peroperative

• Comparison Between Groups of the Time of the Surgery

  Peroperative

• Comparison Between Groups of Anesthesia Time

  Peroperative

Study Arms (2)

double detection Indocyanine + isotope

EXPERIMENTAL

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

Drug: indocyanine green; Drug: isotope

isotope detection alone

ACTIVE COMPARATOR

intradermal injection of 20 MBq of technetium 99 before breast surgery

Drug: isotope

Interventions

indocyanine green DRUG

One injection, 2.5 milligrams per patient, intradermal use

double detection Indocyanine + isotope

isotope DRUG

One injection, 20 MBq techntium99, intradermal use

Also known as: technetium

double detection Indocyanine + isotope; isotope detection alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mammary carcinoma recurrence
• Previous same side mammary reduction
• Previous lumpectomy
• Contra-indication to surgery
• Pregnant or breast feeding patient
• Denial of participation

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green; Isotopes; Technetium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Inorganic Chemicals; Elements, Radioactive; Elements; Metals, Heavy; Transition Elements; Radioisotopes; Metals

Results Point of Contact

• Title: Pr Céline CHAULEUR
• Organization: CHU Saint-Etienne

celine.chauleur@chu-st-etienne.fr

04 77 82 86 11

Study Officials

• Céline CHAULEUR, PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 30, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)