SLN Biopsy for Eyelid Melanoma
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.
Research Team
BE
Bita Esmaeli
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with a specific eye cancer called conjunctival/eyelid melanoma. They must have no signs of the cancer spreading on ultrasound, chest X-ray, liver tests, or head and neck scans. Participants need to give written consent and can't be pregnant or nursing.Inclusion Criteria
I have a confirmed melanoma of the eye or eyelid that is thick or shows signs of severe growth.
You need to have a recent ultrasound showing that the lymph nodes in your body are not swollen.
Your chest X-ray, liver enzymes, and head and neck CT or MRI show no signs of cancer spreading to other parts of your body.
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Exclusion Criteria
Pregnant or nursing females.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Treatment
Participants undergo lymphatic mapping and SLN biopsy to identify microscopic lymph node disease
1 day
1 visit (in-person)
Follow-up
Participants are monitored for disease status with regular eye exams, blood tests, and imaging
5 years
Every 3 months for the first year, then every 6 months
Treatment Details
Interventions
- Sentinel Lymph Node Mapping and Biopsy
Trial Overview The study aims to locate and biopsy the sentinel lymph node(s) in patients with eyelid or conjunctival melanoma to detect any early spread of cancer that might not be otherwise noticed.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Sentinel Lymph Node (SLN) BiopsyExperimental Treatment1 Intervention
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3,107
Recruited
1,813,000+
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