Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin), Squamous Cell Carcinoma, Skin, Cervix Cancer, Endometrium Cancer, Ovary Cancer, Vulva Cancer, Anus Cancer, Rectum Cancer
Conditions
Keywords
Indocyanine green (ICG), Sentinel lymph node biopsy, Technetium99, Tumors, Optonuclear probe, 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
Interventions
DRUGIndocyanine green
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
DRUGTechnetium99
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node
DEVICEOptonuclear 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.
DEVICEQuest Camera
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed