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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Interventions

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

Arms, Groups and Cohorts

  • Experimental: double detection Indocyanine + isotope
    • intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
  • Active Comparator: isotope detection alone
    • intradermal injection of 20 MBq of technetium 99 before breast surgery

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Céline CHAULEUR, PhD, Principal Investigator, Centre Hospitalier Universitaire de Saint Etienne

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