Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
Overview
- Phase
- Phase 2
- Intervention
- Lymph Node Mapping
- Conditions
- Eyelid Sebaceous Gland Carcinoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Sentinel Lymph Node Positivity
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Diagnostic (SLN localization and biopsy)
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
Intervention: Lymph Node Mapping
Diagnostic (SLN localization and biopsy)
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
Intervention: Sentinel Lymph Node Biopsy
Diagnostic (SLN localization and biopsy)
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
Intervention: Technetium Tc-99m Sulfur Colloid
Outcomes
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