Infrared Lymphangiography as a Method of Sentinel Node Identification

Melanoma Clinical Trial

— SPY SN  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057393
• Other study ID #: 247374
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: June 6, 2016
• Start date: June 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The initial treatment for most people with melanoma involves wide excision of the skin and sentinel node biopsy. As with other cancers, the status of the sentinel node provides important prognostic information to the patient and physician. Sentinel node biopsy was first developed using only a blue dye. Technetium99, a radioactive protein, was added later and provides the ability to image the patient and identify relevant lymph node basins. For the last 15 years or so, the standard method of SLN localization includes both tech99 and blue dye. While the rates of localization overall are excellent, these methods each have drawbacks. We are investigating a new method of finding sentinel nodes that uses a green dye that has an infrared signal. Our hypothesis is that indocyanine green (ICG) and real time lymphangiography is equivalent to technetium99 and methylene blue in identifying sentinel nodes (SLN) in patients with melanoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed melanoma.

• All patients with melanoma of the arm, leg or trunk who qualify for a sentinel node biopsy based on the characteristics of their primary tumor are eligible to participate. Patients with melanoma that is T1b or greater are recommended to have a sentinel node biopsy.

• Age >18 years. Melanoma is extremely uncommon in children, this disease is not relevant in this age group.

• The effects of IC-Green on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients with melanoma on the head or neck are excluded

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to IC-Green, sodium iodide or other agents used in the study.

• Pregnant women are excluded from this study

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Sentinel Node

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence of ICG and real time lymphangiography to technetium99 and blue dye in localizing sentinel nodes	The primary outcome measure is the ability of indocyanine green (ICG) and real time lymphangiography, technetium99 and methylene blue to identify sentinel nodes (SLN) in patients with melanoma, and to compare each dye to the others.	2 weeks	No