A Phase 1 interventional study of Sentinel Lymph Node Mapping and Biopsy in Eye Disease and Melanoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Diagnostic
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.
You have had your conjunctival or eyelid tumor surgically removed or it is scheduled to have it removed. You will have lymphatic mapping before the 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.
If you are able to become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy test, within 7 days before the biopsy. To take part in this study, you must not be pregnant.
You will then go to the operating room and have intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, you 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 you 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.
Length of Study:
Your active participation on this study will be over once the biopsy is over. You will continue to be observed on study for 5 years after the biopsy.
Long-Term Follow-Up:
Every 3 months for the first year after the biopsy, and every 6 months after that until 5 years after the biopsy, you will have an eye exam to check the status of the disease.
Every 6 months for the first year after the biopsy, blood (less than 1 teaspoon) will be drawn for liver function tests. You will also have a chest x-ray. You will then have these tests 1 time each year for 5 years after the biopsy.
You will have a head and neck CT or MRI every 6 months for the first year after the biopsy to make sure the disease has not come back. The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy.
This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center.
747 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.
This study's enrollment of 38 is below the median of 69 across 554 interventional studies indexed under Eye Diseases.
Browse Eye Diseases studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
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Exclusion Criteria:
1) Pregnant or nursing females.
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
Procedure: Sentinel Lymph Node Mapping and Biopsy
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
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.
Time frame: 3 months
Ran from May 2000 to primary completion in Sep 2023, 279 months.
Of 25 phase 1 interventional studies under Eye Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 25. This study's 279 months is above that.
Eye Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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