Fluorescence Surgery for Sentinel Node Identification in Melanoma

February 1, 2017 updated by: Barretos Cancer Hospital

Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma

Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.

Study Type

Interventional

Enrollment (Anticipated)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Barretos, SP, Brazil, 14784400
        • Recruiting
        • Barretos Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vinicius L Vazquez, Ph.D
        • Sub-Investigator:
          • Carlos EB Carvalho, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients eligible for sentinel node biopsy in standard care

Exclusion Criteria:

  • Previous neoplasia
  • Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy
  • Local recurrence
  • Hypersensibility or allergy history to indocyanine or Iodine-based contrast media

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Near infra red sentinel node biopsy
Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy.
Procedure: Near infra red sentinel node biopsy
Explicated in the protocol arm
Other Names:
  • Sentinel node biopsy with fluorescence
Drug: Indocyanine green
Explicated in the protocol arm
Device: Intraoperative Near-Infrared Imaging System
Explicated in the protocol arm
Other Names:
  • Photodynamic Eye (PDE)
  • Pulsion
  • MiniFlare
  • The Flare Foundation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility of the sentinel node biopsy
Time Frame: Time of surgery
The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed
Time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of the sentinel node biopsy
Time Frame: 60 months
The false negative sentinel node biopsy rate. The proportion of patients submitted to the procedure with histological negative biopsy, presenting lymph node metastasis at follow up.
60 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 60 months
60 months
Disease free survival
Time Frame: 60 months
Presence and time to disease recurrence or not
60 months
Specific cancer survival
Time Frame: 60 months
Specific melanoma survival
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Investigators

  • Principal Investigator: Vinicius L Vazquez, Ph.D., Barretos Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCHNIR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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