Trial Outcomes & Findings for Infrared Lymphangiography as a Method of Sentinel Node Identification (NCT NCT02057393)

Results Overview

The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

89 participants

Primary outcome timeframe

2 weeks

Results posted on

2017-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Indocyanine Green Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99. Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node. Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node. Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.
Overall Study STARTED	89
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Indocyanine Green Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99. Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node. Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node. Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.
Overall Study Withdrawal by Subject	1
Overall Study Patient did not meet criteria	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indocyanine Green n=87 Participants Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99. Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node. Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node. Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.
Age, Continuous	65 years n=87 Participants
Sex: Female, Male Female	45 Participants n=87 Participants
Sex: Female, Male Male	42 Participants n=87 Participants
Region of Enrollment United States	87 Participants n=87 Participants
BMI	28 kg/m2 n=87 Participants

PRIMARY outcome

Timeframe: 2 weeks

The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.

Outcome measures

Outcome measures
Measure	Indocyanine Green n=87 Participants Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99. Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node. Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node. Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.
Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes	1.87 number of sentinel nodes per patient Standard Deviation 0.95

Adverse Events

Indocyanine Green

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Colette Pameijer, Associate Professor of Surgery

Penn State Hershey Medical Center

Phone: 717-531-5272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place