GASVERT: Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
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 |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
Drug: Technetium99
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.
Lymphoscintigraphy is performed to identify the sentinel node
Other Names:
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.
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Outcome Measures
Primary Outcome Measures
- 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
- Total number of sentinel lymph node detected [1 day]
The total number of sentinel node detected will be assess by the two techniques
- 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
- Allergic reactions [8 days]
Percentage of patients with allergic reactions
- Evaluation of pain [1 day]
Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
- fluorescence imaging [1 day]
The total number of sentinel node detected by fluorescence imaging
Eligibility Criteria
Criteria
Inclusion Criteria:
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age >18 years
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cancer histologically proved
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patient eligible for sentinel node detection
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contraceptive methods for men and women of childbearing age
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signed informed consent form
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patient affiliated to the social security system
Exclusion Criteria:
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neoadjuvant chemotherapy or hormone therapy
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adenopathy (s) clinically suspicious or positively cytopenic
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women who are pregnant or breast-feeding
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associated pathology that may prevent patient of receive indocyanine green
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ongoing participation in another clinical trial with an investigational drug
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patients deprived of liberty or under supervision
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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 | |
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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.- 2016-A00799-42