Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid - NCT00386906-77030 (Clinical Trial 152732)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy152732.aspx
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Eye Disease - Melanoma |
| Purpose: |
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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
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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U.T.M.D. Anderson Cancer Center
Houston, TX 77030
United States
Primary Contact:
Bita Esmaeli, MD
Phone: 713-792-6920 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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