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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Eyelid Sebaceous Gland Carcinoma

Intervention / Treatment
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* Procedure: Lymph Node Mapping
* Procedure: Sentinel Lymph Node Biopsy
* Drug: Technetium Tc-99m Sulfur Colloid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (SLN localization and biopsy)<br>Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy. | Procedure: Lymph Node Mapping<br>* Undergo lymph node mapping<br>* Other names: lymphatic mapping;Procedure: Sentinel Lymph Node Biopsy<br>* Undergo SLN biopsy<br>* Other names: SNB;Drug: Technetium Tc-99m Sulfur Colloid<br>* Given ID<br>* Other names: Technetium Tc 99m Sulfur Colloid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sentinel lymph node (SLN) positivity | Will be reported using descriptive statistics. | At day 1 | 
| Rate of false negative events | Will be reported using descriptive statistics. | At day 1 |