GASVERT: Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Sponsor
Institut de Cancérologie de Lorraine (Other)
Overall Status
Recruiting
CT.gov ID
NCT02997553
Collaborator
(none)
744
1
1
63
11.8

Study Details

Study Description

Brief Summary

This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine green
  • Drug: Technetium99
  • Device: Optonuclear probe
  • Device: Quest Camera
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
744 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
Actual Study Start Date :
Nov 29, 2017
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: sentinel lymph node detection

Each patient receive both injections of Technetium99 (standard care) and indocyanine green. The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

Drug: Indocyanine green
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
Other Names:
  • Infracyanine
  • Drug: Technetium99
    Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node
    Other Names:
  • NANOCIS
  • Device: Optonuclear probe
    The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

    Device: Quest Camera
    The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.

    Outcome Measures

    Primary Outcome Measures

    1. Non-inferiority of indocyanine green guided sentinel lymph node biopsy [1 day]

      The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively. Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.

    Secondary Outcome Measures

    1. Total number of sentinel lymph node detected [1 day]

      The total number of sentinel node detected will be assess by the two techniques

    2. Number of false negative result [1 day]

      False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node

    3. Allergic reactions [8 days]

      Percentage of patients with allergic reactions

    4. Evaluation of pain [1 day]

      Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)

    5. fluorescence imaging [1 day]

      The total number of sentinel node detected by fluorescence imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age >18 years

    • cancer histologically proved

    • patient eligible for sentinel node detection

    • contraceptive methods for men and women of childbearing age

    • signed informed consent form

    • patient affiliated to the social security system

    Exclusion Criteria:
    • neoadjuvant chemotherapy or hormone therapy

    • adenopathy (s) clinically suspicious or positively cytopenic

    • women who are pregnant or breast-feeding

    • associated pathology that may prevent patient of receive indocyanine green

    • ongoing participation in another clinical trial with an investigational drug

    • patients deprived of liberty or under supervision

    • impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut de Cancérologie de Lorraine Vandoeuvre-les-Nancy France 54519

    Sponsors and Collaborators

    • Institut de Cancérologie de Lorraine

    Investigators

    • Principal Investigator: MARCHAL FREDERIC, MD, PU-PH, Institut de Cancérologie de Lorraine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut de Cancérologie de Lorraine
    ClinicalTrials.gov Identifier:
    NCT02997553
    Other Study ID Numbers:
    • 2016-A00799-42
    First Posted:
    Dec 20, 2016
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut de Cancérologie de Lorraine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022