Infrared Lymphangiography as a Method of Sentinel Node Identification
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2014 |
| End Date: | December 2015 |
| Contact: | Colette Pameijer, MD |
| Email: | cpameijer@hmc.psu.edu |
| Phone: | 717-531-5272 |
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.
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.
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
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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