Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

NCT02997553 | Completed Phase 3

• 1 other identifier: 2016-A00799-42
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 1

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

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

Keywords

Indocyanine green (ICG); Sentinel lymph node biopsy; Technetium99; Tumors; Optonuclear probe; Surgery

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of indocyanine green guided sentinel lymph node biopsy

  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.

  1 day

Secondary Outcomes (5)

• Total number of sentinel lymph node detected

  1 day

• Number of false negative result

  1 day

• Allergic reactions

  8 days

• Evaluation of pain

  1 day

• fluorescence imaging

  1 day

Study Arms (1)

sentinel lymph node detection

EXPERIMENTAL

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.

Drug: Indocyanine green; Drug: Technetium99; Device: Optonuclear probe; Device: Quest Camera

Interventions

Indocyanine green DRUG

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

Also known as: Infracyanine

sentinel lymph node detection

Technetium99 DRUG

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

Also known as: NANOCIS

sentinel lymph node detection

Optonuclear probe DEVICE

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 DEVICE

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

sentinel lymph node detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms; Melanoma; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Vulvar Neoplasms; Anus Neoplasms; Rectal Neoplasms; Neoplasms

Interventions

Indocyanine Green; Infracyanine green; Technetium-99; nanocis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vulvar Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• MARCHAL FREDERIC, MD, PU-PH

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: November 29, 2017
• Primary Completion: September 19, 2022
• Study Completion: October 12, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)