Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

  • STATUS
    Recruiting
  • End date
    Mar 3, 2023
  • participants needed
    744
  • sponsor
    Institut de Cancérologie de Lorraine
Updated on 3 February 2021
cancer surgery
cancer
indocyanine green
probe
sentinel node
mammogram
sentinel lymph node biopsy

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

Details
Condition Ductal Carcinoma In Situ, Cervical Cancer, Ovarian disorder, Colorectal Cancer, Disorders of cervix NOS, Endometrial Carcinoma, Rectal Cancer, Uterine Cancer, Breast Cancer, Ovarian Cancer, melanoma, Malignant neoplasm of vulva, skin cancer, Anal Cancer, head and neck cancer, Metastatic Melanoma, Colon Cancer Screening, Colon cancer; rectal cancer, Ovarian Function, Breast Cancer Diagnosis, Vulvar Carcinoma, Recurrent Ovarian Cancer, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Ductal Carcinoma In Situ (DCIS), Squamous Cell Carcinoma, Skin, Squamous Cell Carcinoma, Skin, Endometrial Cancer, Malignant Melanoma, Squamous Cell Carcinoma, Skin, breast carcinoma, cervical carcinoma, anal carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, vulva cancer, cancer of the head and neck, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, ovarian tumors, squamous cell skin cancer, rectal carcinoma
Treatment Indocyanine Green, Technetium99, Optonuclear probe, Quest Camera
Clinical Study IdentifierNCT02997553
SponsorInstitut de Cancérologie de Lorraine
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

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
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