Completed

NCT Number: NCT00832429

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

This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.

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Key information

Conditions

Eyelid Sebaceous Gland Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVES:

I. Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas.

II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas.

SECONDARY OBJECTIVE:

I. Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.

OUTLINE:

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

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Possible or suspicious sebaceous gland carcinoma of the eyelid
A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis
Patient provided written informed consent; in the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants

Exclusion criteria

Pregnant or nursing females

Treatment and study plan

Lymph Node Mapping

Procedure

Undergo lymph node mapping

Other names: lymphatic mapping

Sentinel Lymph Node Biopsy

Procedure

Undergo SLN biopsy

Other names: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Technetium Tc-99m Sulfur Colloid

Drug

Given ID

Other names: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

Primary outcomes

Sentinel Lymph Node Positivity

Time frame: One year after the surgical procedure under study.

Number of patients who had a positive sentinel lymph node

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

Important dates

Study start: 2009
Primary completion: 2024
Study completion: 2024
First posted: Jan 30, 2009
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.