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Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery (GASVERT)

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ClinicalTrials.gov Identifier: NCT02997553
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.).


Condition or disease Intervention/treatment Phase
Breast Carcinoma Head and Neck Cancer Melanoma (Skin) Squamous Cell Carcinoma, Skin Cervix Cancer Endometrium Cancer Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer Drug: Indocyanine green Drug: Technetium99 Device: Optonuclear probe Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 744 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sentinel lymph node detection

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

Drug: Technetium99

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

Lymphoscintigraphy is performed to identify the sentinel node

Other Name: NANOCIS

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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. Pain [ Time Frame: 1 day ]
    Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years
  • cancer histologically proved
  • patient eligible for sentinel node detection
  • first surgical treatment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997553


Contacts
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Contact: MERLIN JEAN LOUIS + 33 3 83 59 83 07 jl.merlin@nancy.unicancer.fr
Contact: FERNANDES LAURINDA + 33 3 83 59 84 87 l.fernandes@nancy.unicancer.fr

Locations
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France
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-les-Nancy, France, 54519
Contact: Marchal Frédéric, MD PU-PH    + 33 3 83 59 84 51    f.marchal@nancy.unicancer.fr   
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: MARCHAL FREDERIC, MD, PU-PH Institut de Cancérologie de Lorraine

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02997553     History of Changes
Other Study ID Numbers: 2016-A00799-42
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de Lorraine:
Indocyanine green (ICG)
Sentinel lymph node biopsy
Technetium99
Tumors
Optonuclear probe
Surgery
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Uterine Cervical Neoplasms
Rectal Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases