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Completed

NCT Number: NCT02279108

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

One injection, 2.5 milligrams per patient, intradermal use

isotope

Drug

One injection, 20 MBq techntium99, intradermal use

Other names: technetium

Primary outcomes

  1. 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 outcomes

  1. Number of Lymph Nodes ICG Positive and Tc Positive

    Time frame: Peroperative

    Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive

  2. Number of Lymph Nodes ICG Positive and Tc Negative

    Time frame: Peroperative

    Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative

  3. Number of Lymph Nodes ICG Negative and Tc Positive

    Time frame: Peroperative

    Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive

  4. Comparison Between Groups of the Time of the Surgery

    Time frame: Peroperative

    time from incision to wound closure

  5. Comparison Between Groups of Anesthesia Time

    Time frame: Peroperative

    time from the injection of anesthesic to the waking

  6. 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

  7. Comparison Between Groups of Time Surgery Node

    Time frame: Peroperative

    time from incision time to the last node surgery

  8. Number of Patients With ICG Allergy

    Time frame: peroperative

    allergy is : redness, edema, itching, larynges edema and/or allergic shock

  9. 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

  10. Number of Patients With ICG Allergy

    Time frame: Month 2

    allergy is : redness, edema, itching, larynges edema and/or allergic shock

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: FLUOTECH

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2014
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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