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Lymph Node Mapping for Eyelid Cancer

Phase 2

Waitlist Available

Led By Bita M Esmaeli

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

Possible or suspicious sebaceous gland carcinoma of the eyelid

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1

Awards & highlights

Study Summary

This trial is testing how well a lymph node mapping technique works in patients with sebaceous gland cancer of the eyelid. The hope is that this technique will help plan surgery to remove cancer and affected lymph nodes.

Who is the study for?

This trial is for individuals with sebaceous gland cancer of the eyelid who have no signs of the cancer spreading, as confirmed by chest x-rays and scans. Participants must understand and sign a consent form. Pregnant or nursing women are not eligible.Check my eligibility

What is being tested?

The study is testing lymph node mapping using Technetium Tc-99m Sulfur Colloid to detect if cancer has spread in patients with eyelid sebaceous gland carcinoma. It aims to improve surgical planning for removing both the tumor and affected lymph nodes.See study design

What are the potential side effects?

Potential side effects may include discomfort at injection site, allergic reactions to the tracer substance (Technetium Tc-99m), and complications from biopsy such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I might have a rare eyelid cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of false negative events

Rate of sentinel lymph node (SLN) positivity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (SLN localization and biopsy)Experimental Treatment3 Interventions

Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lymph Node Mapping

2015

Completed Phase 2

~30

Technetium Tc-99m sulfur colloid

FDA approved

Sentinel Lymph Node Biopsy

2004

Completed Phase 3

~330

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,761 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,133 Total Patients Enrolled

Bita M EsmaeliPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Lymph Node Mapping Clinical Trial Eligibility Overview. Trial Name: NCT00832429 — Phase 2

Eyelid Carcinoma Research Study Groups: Diagnostic (SLN localization and biopsy)

Eyelid Carcinoma Clinical Trial 2023: Lymph Node Mapping Highlights & Side Effects. Trial Name: NCT00832429 — Phase 2

Lymph Node Mapping 2023 Treatment Timeline for Medical Study. Trial Name: NCT00832429 — Phase 2

Frequently Asked Questions

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

What is the FDA's decision on Sentinel Lymph Node Biopsy?

"Sentinel Lymph Node Biopsy is currently in Phase 2 of clinical trials. This means that while there is some evidence supporting its safety, none yet exists to vouch for its efficacy."

Answered by AI

Is the Sentinel Lymph Node Biopsy a common procedure?

"Currently, there are 5 active Sentinel Lymph Node Biopsy trials taking place with 1 in Phase 3. The majority of these studies are based out of Santa Monica,, but 8 total locations across the country are conducting research on Sentinel Lymph Node Biopsy."

Answered by AI

Does this research project break new ground in the medical field?

"Since 2008, there have been 5 ongoing clinical trials for Sentinel Lymph Node Biopsy in 6 cities and 1 country."

Answered by AI

What is the most frequent reason why Sentinel Lymph Node Biopsy is given?

"A common treatment for hypovolaemia is Sentinel Lymph Node Biopsy. Additionally, this procedure can also assist with drainage procedures, detecting pulmonary aspiration of gastric contents, and imaging reticuloendothelial cells in the liver, spleen and bone marrow."

Answered by AI

How many test subjects are needed for this research?

"Unfortunately, this particular clinical trial is no longer enrolling patients. Although, if you are seeking other opportunities, there are currently 2553 trials for carcinoma and 5 Sentinel Lymph Node Biopsy studies that have open enrollment."

Answered by AI

Are new patients still being accepted into this research program?

"Unfortunately, this particular study is not seeking any more patients at the moment. Although, it's important to note that there are 2553 other clinical trials for carcinoma and 5 studies regarding Sentinel Lymph Node Biopsy that are currently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid

2009. "Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00832429.

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