Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01898403
First received: July 3, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This clinical trial studies lymph node mapping using indocyanine green solution in diagnosing patients with malignant melanoma. Diagnostic procedures, such as lymph node mapping using indocyanine green solution, may help find out how far the melanoma has spread and may help in planning cancer treatment.


Condition Intervention
Recurrent Melanoma
Stage IA Melanoma
Stage IB Melanoma
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Drug: indocyanine green solution
Drug: isosulfan blue
Procedure: lymph node mapping
Procedure: sentinel lymph node biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Testing the Efficacy of Indocyanine Green Imaging ( ICG-SPY ) in the Identification of Sentinel Lymph Nodes ( SLN ) in Patients With Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Mapping of the Sentinel Lymph Nodes (SLN) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    SLN will be identified and mapped using indocyanine green solution, isosulfan blue, and TSC. Participants will undergo peri-tumoral, intradermal injection of ISB AND ICG, in addition intra-operatively the SPY camera will be ued to identify SLN and take images.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (indocyanine green solution, isosulfan blue)
Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).
Drug: indocyanine green solution
Given peri-tumoral and intradermally
Other Names:
  • IC-GREEN
  • ICG solution
Drug: isosulfan blue
Given peri-tumoral and intradermally
Other Names:
  • Lymphazurin
  • N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Procedure: lymph node mapping
Undergo lymph node mapping
Procedure: sentinel lymph node biopsy
Undergo SNLB
Other Name: sentinel node biopsy

Detailed Description:

PRIMARY OBJECTIVES:

I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and willingness to sign informed consent document
  • Signed written informed consent
  • Patients with malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
  • Complete blood count (CBC) and metabolic panel within 6 months

Exclusion Criteria:

  • History of hepatic or renal failure
  • Allergy to iodine containing products
  • Patients who are pregnant or may be pregnant
  • Patients with psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898403

Locations
United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ralph Greco Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01898403     History of Changes
Other Study ID Numbers: MEL0010, NCI-2013-01286, 27319, P30CA124435
Study First Received: July 3, 2013
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014