Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma

NCT00386906 | Completed Phase 1

• 2 other identifiers: GSP00-106NCI-2012-01480
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.

Conditions

Eye Disease; Melanoma

Keywords

Melanoma; Conjunctival Melanoma; Malignant Melanoma of the Conjunctiva; Malignant Melanoma of the Eyelid; Sebaceous Cell Carcinoma; Sebaceous Cell Carcinoma of the Conjunctiva; Sebaceous Cell Carcinoma of the Eyelid; Sentinel Lymph Node; Lymphatic Mapping; Eyelid; Eyelid Lesion

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas

  The frequency of lymphatic drainage basins for bulbar versus palpebral conjunctiva and for nasal and the temporal quadrants estimated with 95% confidence intervals. The rate of identification of SLN evaluated with a confidence interval. The probability of positive SLN in primary conjunctival and eyelid melanoma estimated.

  3 months

Study Arms (1)

Sentinel Lymph Node (SLN) Biopsy

OTHER

Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Procedure: Sentinel Lymph Node Mapping and Biopsy

Interventions

Sentinel Lymph Node Mapping and Biopsy PROCEDURE

Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Sentinel Lymph Node (SLN) Biopsy

Eligibility Criteria

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

You may qualify if:

• Participants must be 18 years of age or older.
• Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV.
• A CXR, liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis.
• Participant must have a negative ultrasound of regional lymph nodes (i.e., within 6 weeks of study enrollment).
• 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 ICD in their language, will be utilized and completed in accordance with the 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

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Eye Diseases; Melanoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bita Esmaeli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: May 30, 2000
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

US (1)