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

M.D. Anderson Cancer Center20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Eyelid Sebaceous Gland Carcinoma

Interventions

Lymph Node MappingPROCEDURE

Undergo lymph node mapping

Sentinel Lymph Node BiopsyPROCEDURE

Undergo SLN biopsy

Technetium Tc-99m Sulfur ColloidDRUG

Given ID

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Sentinel Lymph Node Positivity

Number of patients who had a positive sentinel lymph node

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

Data from ClinicalTrials.gov

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