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

Phase 2

Active, not recruiting

• Conditions: Eyelid Sebaceous Gland Carcinoma
• Interventions: Procedure: Lymph Node Mapping; Procedure: Sentinel Lymph Node Biopsy; Drug: Technetium Tc-99m Sulfur Colloid

• Registration Number: NCT00832429
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Study Start: 2009-02-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10
• Primary Completion: 2026-10-13
• Study Completion: 2026-10-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Pregnant or nursing females

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (SLN localization and biopsy)	Sentinel Lymph Node Biopsy	Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
Diagnostic (SLN localization and biopsy)	Lymph Node Mapping	Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
Diagnostic (SLN localization and biopsy)	Technetium Tc-99m Sulfur Colloid	Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.

Primary Outcome Measures

Name	Time	Method
Rate of sentinel lymph node (SLN) positivity	At day 1	Will be reported using descriptive statistics.
Rate of false negative events	At day 1	Will be reported using descriptive statistics.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States