Trial Outcomes & Findings for Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma (NCT NCT01898403)
NCT ID: NCT01898403
Last Updated: 2017-05-24
Results Overview
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2017-05-24
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Sentinel Lymph Node (SLN) Detection
n=50 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
60.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: All participants were evaluated for sentinel lymph nodes (SLN) using Isosulfan Blue (ISB); Indocyanine Green (ICG); and TSC lymphoscintigraphy.
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
Outcome measures
| Measure |
Sentinel Lymph Node (SLN) Detection by Isosulfan Blue
n=61 Sentinel Lymph Nodes
All patients received 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.
|
Sentinel Lymph Node (SLN) Detection by Indocyanine Green
n=61 Sentinel Lymph Nodes
All patients received 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.
|
Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy
n=61 Sentinel Lymph Nodes
All patients received 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.
|
|---|---|---|---|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by TSC only
|
0 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
3 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ISB, ICG, and TSC
|
25 Sentinel lymph nodes
|
25 Sentinel lymph nodes
|
25 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ISB and TSC only
|
4 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
4 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ICG and TSC only
|
0 Sentinel lymph nodes
|
9 Sentinel lymph nodes
|
9 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ISB and ICG only
|
10 Sentinel lymph nodes
|
10 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ISB plus any/none
|
41 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ISB only
|
2 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ICG plus any/none
|
0 Sentinel lymph nodes
|
47 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by ICG only
|
0 Sentinel lymph nodes
|
3 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
|
Sentinel Lymph Nodes (SLN) Mapping
SLN detected by TSC plus any/none
|
0 Sentinel lymph nodes
|
0 Sentinel lymph nodes
|
41 Sentinel lymph nodes
|
Adverse Events
Sentinel Lymph Node (SLN) Detection
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sentinel Lymph Node (SLN) Detection
n=50 participants at risk
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)
|
|---|---|
|
Infections and infestations
Infection
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
8.0%
4/50 • Number of events 4
|
Additional Information
Dana T Lin, MD; Clinical Assistant Professor
Stanford University Medical Center
Phone: 650-498-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place