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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ralph Greco, Stanford University
ClinicalTrials.gov Identifier:
NCT01898403
First received: July 3, 2013
Last updated: April 19, 2017
Last verified: June 2015
  Purpose

This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).

Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.


Condition Intervention
Recurrent Melanoma Drug: Indocyanine green solution Drug: Isosulfan blue (ISB) Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 Ralph Greco, Stanford University:

Primary Outcome Measures:
  • Sentinel Lymph Nodes (SLN) Mapping [ Time Frame: Up to 1 year ]
    Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.


Enrollment: 50
Study Start Date: June 2013
Study Completion Date: April 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sentinel Lymph Node (SLN) Detection
All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
Drug: Indocyanine green solution
Administered peri-tumoral and intradermally
Other Names:
  • IC-GREEN (ICG)
  • ICG solution
Drug: Isosulfan blue (ISB)
Administered peri-tumoral and intradermally
Other Names:
  • Lymphazurin
  • N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Other Name: TSC lymph node mapping

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

Inclusion Criteria:

  • Ability to understand and willingness to sign informed consent document
  • Signed written informed consent
  • Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
  • 18 years of age or older
  • Complete blood count (CBC) and metabolic panel within 6 months

Exclusion Criteria:

  • History of hepatic or renal failure
  • Allergy to iodine containing products
  • Pregnant or may be pregnant
  • Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
  • Undergoing dialysis
  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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ralph Greco Stanford University Hospitals and Clinics
  More Information

Responsible Party: Ralph Greco, Johnson and Johnson Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT01898403     History of Changes
Other Study ID Numbers: IRB-27319
NCI-2013-01286 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MEL0010 ( Other Identifier: OnCore )
P30CA124435 ( US NIH Grant/Contract Award Number )
Study First Received: July 3, 2013
Results First Received: February 24, 2017
Last Updated: April 19, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on June 22, 2017