Infrared Lymphangiography as a Method of Sentinel Node Identification (SPY-SN)

• ClinicalTrials.gov Identifier: NCT02057393
• Recruitment Status: Completed
• First Posted: February 7, 2014
• Results First Posted: June 6, 2017
• Last Update Posted: July 6, 2017
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Colette Pameijer, Milton S. Hershey Medical Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Conditions: Melanoma; Sentinel Node
• Interventions: Drug: Indocyanine green; Drug: Technetium99; Drug: Methylene blue
• Enrollment: 89

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Indocyanine Green
Arm/Group Description	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.
Period Title: Overall Study
Started	89
Completed	87
Not Completed	2
Reason Not Completed
Withdrawal by Subject	1
Patient did not meet criteria	1

Baseline Characteristics

Arm/Group Title		Indocyanine Green
Arm/Group Description		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 Number of Baseline Participants		87
Baseline Analysis Population Description		89 subjects were enrolled, one subject retracted consent, and another was deemed ineligible after enrollment, leaving 87 evaluable participants.
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	87 participants
		65; (26 to 94)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	87 participants
	Female	45 51.7%
	Male	42 48.3%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	87 participants
		87 100.0%
BMI; Median (Full Range); Unit of measure: Kg/m2
	Number Analyzed	87 participants
		28; (17 to 51.5)

Outcome Measures

1. Primary Outcome

Title	Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Indocyanine Green
Arm/Group Description:	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 Number of Participants Analyzed	87
Mean (Standard Deviation); Unit of Measure: number of sentinel nodes per patient
	1.87 (0.95)

Adverse Events

Time Frame	2 weeks post-op
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Indocyanine Green
Arm/Group Description	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.
All-Cause Mortality
	Indocyanine Green
	Affected / at Risk (%)
Total	0/87 (0.00%)
Serious Adverse Events
	Indocyanine Green
	Affected / at Risk (%)
Total	0/87 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Indocyanine Green
	Affected / at Risk (%)
Total	0/87 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Colette Pameijer, Associate Professor of Surgery
• Organization: Penn State Hershey Medical Center
• Phone: 717-531-5272
• EMail: cpameijer@pennstatehealth.psu.edu

Publications:

Jain V, Phillips BT, Conkling N, Pameijer C. Sentinel lymph node detection using laser-assisted indocyanine green dye lymphangiography in patients with melanoma. Int J Surg Oncol. 2013;2013:904214. doi: 10.1155/2013/904214. Epub 2013 Dec 8.

• Responsible Party: Colette Pameijer, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02057393
• Other Study ID Numbers: 247374
• First Submitted: January 24, 2014
• First Posted: February 7, 2014
• Results First Submitted: March 17, 2017
• Results First Posted: June 6, 2017
• Last Update Posted: July 6, 2017