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

NCT ID: NCT02279108

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

double detection Indocyanine + isotope

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

Group Type: EXPERIMENTAL

indocyanine green

Intervention Type: DRUG

One injection, 2.5 milligrams per patient, intradermal use

isotope

Intervention Type: DRUG

One injection, 20 MBq techntium99, intradermal use

isotope detection alone

intradermal injection of 20 MBq of technetium 99 before breast surgery

Group Type: ACTIVE_COMPARATOR

isotope

Intervention Type: DRUG

One injection, 20 MBq techntium99, intradermal use

Interventions

indocyanine green

One injection, 2.5 milligrams per patient, intradermal use

Intervention Type: DRUG

isotope

One injection, 20 MBq techntium99, intradermal use

Intervention Type: DRUG

Other Intervention Names

technetium

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline CHAULEUR, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2014-004005-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1408153

Identifier Type: -

Identifier Source: org_study_id