Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

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Vulvar cancer
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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

January 2021