Eye DiseasePhase 1NCT00386906
Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma
A Phase 1 study testing Sentinel Lymph Node Mapping and Biopsy in people with Eye Disease and Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Disease, Melanoma
- What is being tested?
- Sentinel Lymph Node Mapping and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2000to 28 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
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.
Read the detailed description
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.
- Conditions
- Eye Disease, Melanoma
- Being tested
- Sentinel Lymph Node Mapping and Biopsy
- 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
- Medical subject headings
- Eye Diseases, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node Mapping and BiopsyProcedure or surgery
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node (SLN) Biopsy | Other | Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor. Receives: Procedure: Sentinel Lymph Node Mapping and Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study start30 May 2000
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bita Esmaeli, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386906
- Sponsor's protocol ID
- GSP00-106
- Other IDs
- NCI-2012-01480
- Status last verified
- Apr 2025
- First submitted
- 10 Oct 2006
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
- ClinicalTrials.gov ID
- NCT00386906
- Acronym / sponsor ID
- GSP00-106
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 May 2000 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node (SLN) Biopsy | Other | Procedure: Sentinel Lymph Node Mapping and BiopsyIntraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Pregnant or nursing females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node Mapping and BiopsyIntraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor. | Procedure or surgery | Sentinel Lymph Node (SLN) Biopsy |
Primary outcome
Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bita Esmaeli, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sentinel Lymph Node Mapping and Biopsy in people with Eye Disease and Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.