Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Phase 3

Completed

• Conditions: Endometrium Cancer; Ovary Cancer; Squamous Cell Carcinoma, Skin; Breast Carcinoma; Anus Cancer; Head and Neck Cancer; Melanoma (Skin); Cervix Cancer; Vulva Cancer; Rectum Cancer
• Interventions: Drug: Indocyanine green; Drug: Technetium99; Device: Optonuclear probe; Device: Quest Camera

• Registration Number: NCT02997553
• Lead Sponsor: Institut de Cancérologie de Lorraine

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Study Start: 2017-11-29
• Primary Completion: 2022-09-19
• Study Completion: 2022-10-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 744

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sentinel lymph node detection	Optonuclear probe	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.
sentinel lymph node detection	Quest Camera	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.
sentinel lymph node detection	Technetium99	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.
sentinel lymph node detection	Indocyanine green	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-les-Nancy, France