Brief Title
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
Official Title
Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
Secondary Outcome
Total number of sentinel lymph node detected
Condition
Breast Carcinoma
Intervention
Indocyanine green
Study Arms / Comparison Groups
sentinel lymph node detection
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
744
Start Date
November 29, 2017
Completion Date
March 2023
Primary Completion Date
November 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
MARCHAL FREDERIC, MD, PU-PH, + 33 3 83 59 83 07, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02997553
Organization ID
2016-A00799-42
Responsible Party
Sponsor
Study Sponsor
Institut de Cancérologie de Lorraine
Study Sponsor
MARCHAL FREDERIC, MD, PU-PH, Principal Investigator, Institut de Cancérologie de Lorraine
Verification Date
March 2022