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

NCT00832429 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2008-0266NCI-2011-01097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Eyelid Sebaceous Gland Carcinoma

Outcome Measures

Primary Outcomes (1)

• Sentinel Lymph Node Positivity

  Number of patients who had a positive sentinel lymph node

  One year after the surgical procedure under study.

Study Arms (1)

Diagnostic (SLN localization and biopsy)

EXPERIMENTAL

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

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

Interventions

Lymph Node Mapping PROCEDURE

Undergo lymph node mapping

Also known as: lymphatic mapping

Diagnostic (SLN localization and biopsy)

Sentinel Lymph Node Biopsy PROCEDURE

Undergo SLN biopsy

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Diagnostic (SLN localization and biopsy)

Technetium Tc-99m Sulfur Colloid DRUG

Given ID

Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

Diagnostic (SLN localization and biopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing females

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Results Point of Contact

• Title: Sara Hull
• Organization: M D Anderson Cancer Center

sehull@mdanderson.org

713-563-4598

Study Officials

• Bita M Esmaeli

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: February 25, 2009
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-07

Locations

US (1)