Head and Neck Cancer Clinical Trial
— GASVERTOfficial title:
Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
Verified date | January 2023 |
Source | Institut de Cancérologie de Lorraine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | Institut de Cancérologie de Lorraine | Vandoeuvre-les-Nancy |
Lead Sponsor | Collaborator |
---|---|
Institut de Cancérologie de Lorraine |
France,
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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