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Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

NCT02997553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2023-01-09

No results posted yet for this study

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

Conditions

  • Breast Carcinoma
  • Head and Neck Cancer
  • Melanoma (Skin)
  • Squamous Cell Carcinoma, Skin
  • Cervix Cancer
  • Endometrium Cancer
  • Ovary Cancer
  • Vulva Cancer
  • Anus Cancer
  • Rectum Cancer

Interventions

DRUG

Indocyanine green

Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)

DRUG

Technetium99

Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node

DEVICE

Optonuclear 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.

DEVICE

Quest Camera

The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.

Sponsors & Collaborators

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • MARCHAL FREDERIC, MD, PU-PH · Institut de Cancérologie de Lorraine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2022-09-19
Completion
2022-10-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02997553 on ClinicalTrials.gov