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

Primary Purpose

Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin)

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Indocyanine green
Technetium99
Optonuclear probe
Quest Camera
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma focused on measuring Indocyanine green (ICG), Sentinel lymph node biopsy, Technetium99, Tumors, Optonuclear probe, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sentinel lymph node detection

Arm Description

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.

Outcomes

Primary Outcome Measures

Non-inferiority of indocyanine green guided sentinel lymph node biopsy
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

Total number of sentinel lymph node detected
The total number of sentinel node detected will be assess by the two techniques
Number of false negative result
False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node
Allergic reactions
Percentage of patients with allergic reactions
Evaluation of pain
Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
fluorescence imaging
The total number of sentinel node detected by fluorescence imaging

Full Information

First Posted
December 16, 2016
Last Updated
January 6, 2023
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02997553
Brief Title
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
Acronym
GASVERT
Official Title
Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin), Squamous Cell Carcinoma, Skin, Cervix Cancer, Endometrium Cancer, Ovary Cancer, Vulva Cancer, Anus Cancer, Rectum Cancer
Keywords
Indocyanine green (ICG), Sentinel lymph node biopsy, Technetium99, Tumors, Optonuclear probe, Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
744 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sentinel lymph node detection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
Infracyanine
Intervention Description
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
Intervention Type
Drug
Intervention Name(s)
Technetium99
Other Intervention Name(s)
NANOCIS
Intervention Description
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node
Intervention Type
Device
Intervention Name(s)
Optonuclear probe
Intervention Description
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
Intervention Type
Device
Intervention Name(s)
Quest Camera
Intervention Description
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
Primary Outcome Measure Information:
Title
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Total number of sentinel lymph node detected
Description
The total number of sentinel node detected will be assess by the two techniques
Time Frame
1 day
Title
Number of false negative result
Description
False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node
Time Frame
1 day
Title
Allergic reactions
Description
Percentage of patients with allergic reactions
Time Frame
8 days
Title
Evaluation of pain
Description
Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
Time Frame
1 day
Title
fluorescence imaging
Description
The total number of sentinel node detected by fluorescence imaging
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCHAL FREDERIC, MD, PU-PH
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54519
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

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