N/A
N=89
Infrared Lymphangiography as a Method of Sentinel Node Identification
Melanoma · Sentinel Node
Bottom Line
View on ClinicalTrials.gov: NCT02057393 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes — 1.87 number of sentinel nodes per patient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indocyanine green (Drug); Technetium99 (Drug); Methylene blue (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes |
1.87 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02057393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.