Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery (GASVERT)

January 6, 2023 updated by: Institut de Cancérologie de Lorraine

Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

744

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-les-Nancy, France, 54519
        • Institut de Cancerologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of sentinel lymph node detected
Time Frame: 1 day
The total number of sentinel node detected will be assess by the two techniques
1 day
Number of false negative result
Time Frame: 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
1 day
Allergic reactions
Time Frame: 8 days
Percentage of patients with allergic reactions
8 days
Evaluation of pain
Time Frame: 1 day
Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
1 day
fluorescence imaging
Time Frame: 1 day
The total number of sentinel node detected by fluorescence imaging
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

October 12, 2022

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00799-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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