Status:
COMPLETED
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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). ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01898403
Start Date
June 1 2013
End Date
April 1 2015
Last Update
May 24 2017
Active Locations (1)
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1
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305