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NCT02997553 Clinical Trial

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Head and Neck Cancer Clinical Trial

— GASVERT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02997553
Other study ID # 2016-A00799-42
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 29, 2017
Est. completion date October 12, 2022

Study information
Verified date January 2023
Source Institut de Cancérologie de Lorraine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 744
Est. completion date October 12, 2022
Est. primary completion date September 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Indocyanine green
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
• Technetium99
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node
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.
• Quest Camera
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.

Locations
Country Name City State
France Institut de Cancérologie de Lorraine Vandoeuvre-les-Nancy

Sponsors (1)
Lead Sponsor Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 1 day
Secondary Total number of sentinel lymph node detected The total number of sentinel node detected will be assess by the two techniques 1 day
Secondary 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 1 day
Secondary Allergic reactions Percentage of patients with allergic reactions 8 days
Secondary Evaluation of pain Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain) 1 day
Secondary fluorescence imaging The total number of sentinel node detected by fluorescence imaging 1 day
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