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Procedure

SLN Biopsy for Eyelid Melanoma

Phase 1
Waitlist Available
Led By Bita Esmaeli, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV.
Participants must be 18 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to find small or low volume metastatic disease that would otherwise have been missed.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, risk of infection from the procedure, allergic reactions to dyes used in mapping, and general risks associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed melanoma of the eye or eyelid that is thick or shows signs of severe growth.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sentinel Lymph Node (SLN) BiopsyExperimental Treatment1 Intervention
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,770 Total Patients Enrolled
108 Trials studying Melanoma
25,944 Patients Enrolled for Melanoma
Bita Esmaeli, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
45 Total Patients Enrolled
~1 spots leftby Apr 2025
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