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Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid - NCT00386906-77030(Clinical Trial 152732)



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City:  Houston
State:  
TX
Zip Code: 77030
Conditions: Eye Disease - Melanoma
Purpose: 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. Objectives: Primary Objectives: 1. Identify the rate of SLN positivity in conjunctival/eyelid melanomas. 2. 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.
Study summary: 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. Your medical record will be reviewed, and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease. The information collected from your medical records will include information about your sex, age, what type of cancer that you have, as well as the size of the cancer and its location. 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.
Criteria: Inclusion Criteria: 1. Participants must be 18 years of age or older. 2. Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness 3. Ability to undergo surgery under general anesthesia 4. A chest X-ray (CXR), liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis 5. Participants must have a negative ultrasound of regional lymph nodes. 6. Capable of giving written informed consent 7. Women of childbearing potential are not eligible unless tested negative for pregnancy prior to SLN mapping and biopsy. Exclusion Criteria: N/A
Study is available at: UT MD Anderson Cancer Center
Houston, TX 77030
United States

Primary Contact:
Bita Esmaeli, MD
Phone: 713-792-6920
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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