NCT01898403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 24, 2017

Completed
Last Updated

May 24, 2017

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

July 3, 2013

Results QC Date

February 24, 2017

Last Update Submit

April 19, 2017

Conditions

Recurrent Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Study Arms (1)

Sentinel Lymph Node (SLN) Detection

EXPERIMENTAL

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 solutionDrug: Isosulfan blue (ISB)Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Interventions

Indocyanine green solutionDRUG

Administered peri-tumoral and intradermally

Also known as: IC-GREEN (ICG), ICG solution
Sentinel Lymph Node (SLN) Detection
Isosulfan blue (ISB)DRUG

Administered peri-tumoral and intradermally

Also known as: Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Sentinel Lymph Node (SLN) Detection
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)DIAGNOSTIC_TEST
Also known as: TSC lymph node mapping
Sentinel Lymph Node (SLN) Detection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Indocyanine Greeniso-sulfan blueLymphoscintigraphy

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsRadionuclide ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Radioisotope

Results Point of Contact

Title
Dana T Lin, MD; Clinical Assistant Professor
Organization
Stanford University Medical Center
danalin@stanford.edu
650-498-6000

Study Officials

  • Ralph Greco

    Stanford University Hospitals and Clinics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Johnson and Johnson Professor of Surgery

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 12, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

April 1, 2015

Last Updated

May 24, 2017

Results First Posted

May 24, 2017

Record last verified: 2015-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)