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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Eyelid Sebaceous Gland Carcinoma

Treatments: Drug: Technetium Tc-99m Sulfur Colloid; Procedure: Lymph Node Mapping; Procedure: Sentinel Lymph Node Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00832429

NCI-2011-01097 (Registry Identifier)

2008-0266

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Diagnostic (SLN localization and biopsy)

Experimental group

Description:

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

Treatment:

Procedure: Sentinel Lymph Node Biopsy

Procedure: Lymph Node Mapping

Drug: Technetium Tc-99m Sulfur Colloid