SLN Biopsy for Eyelid Melanoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Nursing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to detect hidden spread of melanoma in the eyelid area. It uses sentinel lymph node mapping and biopsy, where doctors identify and remove a small group of lymph nodes to check for cancer cell spread. This process helps detect tiny cancer spread that might otherwise go unnoticed. Ideal participants have melanoma on the eyelid or conjunctiva that is over 1 millimeter thick or has certain aggressive features, with no visible signs of cancer spread elsewhere. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for sentinel lymph node biopsy in eyelid melanoma?

Research has shown that sentinel lymph node biopsy (SLNB) is generally safe for patients. This procedure has been used in numerous studies involving skin cancer, with 197 reported biopsies. These studies included patients with skin cancer on the eyelid and the clear tissue covering the eye.

In these studies, the SLNB technique helped identify hidden cancer that might have been missed otherwise. Although the studies did not specifically focus on side effects, the biopsy has been performed many times without major reports of harm. The goal is to detect early signs of cancer spread, which is crucial for treatment.

Since this trial is in an early phase, researchers are primarily examining the safety of SLNB. Early-phase trials often involve close monitoring to ensure the procedure is well-tolerated. The use of SLNB for other conditions suggests some level of safety, but this specific application is still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Sentinel Lymph Node (SLN) Biopsy for eyelid melanoma because it offers a more targeted approach to treatment. Unlike traditional methods that may involve extensive surgery or radiation, SLN biopsy pinpoints the exact lymph nodes affected by cancer. This technique involves intraoperative lymphatic mapping and biopsy, allowing doctors to remove only the necessary tissue. This precision reduces the likelihood of unnecessary removal of healthy tissue, potentially leading to faster recovery and fewer side effects for patients.

What evidence suggests that this technique is effective for detecting metastatic disease in eyelid melanoma?

Research has shown that sentinel lymph node biopsy (SLNB), a procedure participants in this trial will undergo, can detect hidden cancer spread in patients with eyelid melanoma. Past studies found SLNB effective in locating lymph nodes that might contain cancer cells not visible with other methods. This technique helps doctors identify and remove these lymph nodes, potentially catching the disease earlier than other tests. Studies have found SLNB to be a safe and helpful tool for managing eyelid and eye-related melanomas. Detecting cancer early with SLNB could lead to better treatment outcomes for patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Bita Esmaeli

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Pregnant or nursing females.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Sentinel Lymph Node (SLN) Biopsy Experimental Treatment 1 Intervention

Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4548266/

Sentinel Lymph Node Biopsy for Eyelid and Conjunctival ... In this article, we discuss the advances in SLN biopsies over the past decades and the latest evidence on the benefits and pitfalls of this procedure based on ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00386906

Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid ... A total of 38 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center. Official Title. Sentinel Lymph Node Localization and ...

3. mdpi.com mdpi.com/1422-0067/26/19/9469

Sentinel Lymph Node Biopsy in Melanoma: Overview and ... Pre-operative lymphatic mapping is a critical step in sentinel lymph node biopsy for melanoma, facilitating the accurate identification and subsequent removal ...

4. aaojournal.org aaojournal.org/article/S0161-6420(20)30704-1/fulltext

Sentinel Lymph Node Biopsy for Eyelid and Conjunctival ... To determine the efficacy and safety of sentinel lymph node biopsy (SLNB) in the management of eyelid and conjunctival malignancy.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642009003649

Sentinel Lymph Node Biopsy for Ocular Adnexal Melanoma Purpose. To report the findings on sentinel lymph node biopsy (SLNB) in 30 patients with ocular adnexal (conjunctival or eyelid) melanomas.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642020307041

Sentinel Lymph Node Biopsy for Eyelid and Conjunctival ... All 27 studies were rated level III, and a total of 197 SLNBs were reported. Diagnoses included conjunctival and eyelid cutaneous melanoma (85 and 42 patients, ...