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Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid

2014-08-27 03:42:07 | BioPortfolio

Summary

The goal of this clinical research study is to localize 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.

Primary Objectives:

- Identify the rate of sentinel lymph node (SLN) positivity in conjunctival/eyelid melanomas

- Determine the false negative rate for SLN biopsy for the same

Secondary Objective:

- Determine the complication rate for this technique, particularly with respect to local ocular and periocular side effects as well as the risk of facial nerve damage

Description

Patients in this study have had their conjunctival or eyelid tumor surgically removed or is scheduled to have it removed. Patients will have lymphatic mapping before their tumor is removed. Lymphatic mapping is when a small volume of Tc99m-Sulfur colloid is injected by an ophthalmologist after which some radiologic images are taken.

Patients will then go to the operating room and undergo intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, patients will go on to have complete lymph node dissection, which involves removal of all the lymph nodes around the positive SLN. Then the disease will be restaged and patients may require further treatment after consultation with their oncologist.

Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious. With this technique, researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced. Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup, which is routine for conjunctival/eyelid melanoma.

This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at M.D. Anderson Cancer Center.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Eye Disease

Intervention

Sentinel Lymph Node Mapping and Biopsy

Location

U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:07-0400

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