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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

Study 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.Check my eligibility

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.See study design

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

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I have a confirmed melanoma of the eye or eyelid that is thick or shows signs of severe growth.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,743 Total Patients Enrolled

102 Trials studying Melanoma

25,297 Patients Enrolled for Melanoma

Bita Esmaeli, MDPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

45 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its stamp of approval to this therapeutic approach?

"Our team at Power has rated the current level of safety for this treatment to be a 1 due to it being in Phase 1 trials, wherein there is scant data regarding effectiveness and security."

Answered by AI

Are there openings for volunteers in this clinical research?

"According to clinicaltrials.gov, this particular medical trial is no longer actively seeking new participants having been first posted on May 1st 2000 and last updated June 29th 2022. Despite the cessation of recruitment for this study, there are 850 other trials that require patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma

2000. "Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00386906.

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