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NCT Number: NCT02997553

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

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

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Key information

Conditions

Breast Carcinoma Adnexal Diseases Anus Cancer Anus Diseases Anus Neoplasms Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Squamous Cell Cervix Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Endometrium Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Melanoma Melanoma (Skin) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Ovary Cancer Rectal Diseases Rectal Neoplasms Rectum Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma, Skin Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vulva Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

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

Other names: Infracyanine

Technetium99

Drug

Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.

Lymphoscintigraphy is performed to identify the sentinel node

Other names: NANOCIS

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.

Quest Camera

Device

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

Primary outcomes

  1. Non-inferiority of indocyanine green guided sentinel lymph node biopsy

    Time frame: 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 outcomes

  1. Total number of sentinel lymph node detected

    Time frame: 1 day

    The total number of sentinel node detected will be assess by the two techniques

  2. Number of false negative result

    Time frame: 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

  3. Allergic reactions

    Time frame: 8 days

    Percentage of patients with allergic reactions

  4. Evaluation of pain

    Time frame: 1 day

    Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)

  5. fluorescence imaging

    Time frame: 1 day

    The total number of sentinel node detected by fluorescence imaging

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

Acronym: GASVERT

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2016
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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