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

Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01898403
Enrollment
50
Registered
2013-07-12
Start date
2013-06-30
Completion date
2015-04-30
Last updated
2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Melanoma

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).

Interventions

DRUGIndocyanine green solution

Administered peri-tumoral and intradermally

DRUGIsosulfan blue (ISB)

Administered peri-tumoral and intradermally

DIAGNOSTIC_TESTLymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sentinel Lymph Nodes (SLN) MappingUp to 1 yearSentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Indocyanine green solution: Administered peri-tumoral and intradermally Isosulfan blue (ISB): Administered peri-tumoral and intradermally Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
50
Total50

Baseline characteristics

CharacteristicSentinel Lymph Node (SLN) Detection
Age, Categorical
<=18 years
1 Participants
Age, Categorical
>=65 years
18 Participants
Age, Categorical
Between 18 and 65 years
31 Participants
Age, Continuous60.7 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
44 Participants
Region of Enrollment
United States
50 participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
32 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 50
other
Total, other adverse events
5 / 50
serious
Total, serious adverse events
0 / 50

Outcome results

Primary

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.

Time frame: Up to 1 year

Population: All participants were evaluated for sentinel lymph nodes (SLN) using Isosulfan Blue (ISB); Indocyanine Green (ICG); and TSC lymphoscintigraphy.

ArmMeasureGroupValue (NUMBER)
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by TSC only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ISB and TSC only4 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ICG and TSC only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ISB and ICG only10 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ISB plus any/none41 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ISB only2 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ICG plus any/none0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ICG only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by TSC plus any/none0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Isosulfan BlueSentinel Lymph Nodes (SLN) MappingSLN detected by ISB, ICG, and TSC25 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ISB only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ISB, ICG, and TSC25 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ISB plus any/none0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by TSC only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ISB and TSC only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by TSC plus any/none0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ICG only3 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ICG and TSC only9 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ICG plus any/none47 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by Indocyanine GreenSentinel Lymph Nodes (SLN) MappingSLN detected by ISB and ICG only10 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ICG only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ISB and ICG only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by TSC only3 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ISB plus any/none0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ISB only0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by TSC plus any/none41 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ICG plus any/none0 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ISB, ICG, and TSC25 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ISB and TSC only4 Sentinel lymph nodes
Sentinel Lymph Node (SLN) Detection by TSC LymphoscintigraphySentinel Lymph Nodes (SLN) MappingSLN detected by ICG and TSC only9 Sentinel lymph nodes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026