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

Primary Purpose

Recurrent Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indocyanine green solution
Isosulfan blue (ISB)
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sentinel Lymph Node (SLN) Detection

Arm Description

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.

Outcomes

Primary Outcome Measures

Sentinel Lymph Nodes (SLN) Mapping
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2013
Last Updated
April 19, 2017
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01898403
Brief Title
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
Official Title
Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sentinel Lymph Node (SLN) Detection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green solution
Other Intervention Name(s)
IC-GREEN (ICG), ICG solution
Intervention Description
Administered peri-tumoral and intradermally
Intervention Type
Drug
Intervention Name(s)
Isosulfan blue (ISB)
Other Intervention Name(s)
Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Intervention Description
Administered peri-tumoral and intradermally
Intervention Type
Diagnostic Test
Intervention Name(s)
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Other Intervention Name(s)
TSC lymph node mapping
Primary Outcome Measure Information:
Title
Sentinel Lymph Nodes (SLN) Mapping
Description
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Greco
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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