Eyelid Sebaceous Gland CarcinomaPhase 2NCT00832429
Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid
A Phase 2 study testing Lymph Node Mapping, Sentinel Lymph Node Biopsy and Technetium Tc-99m Sulfur Colloid in people with Eyelid Sebaceous Gland Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyelid Sebaceous Gland Carcinoma
- What is being tested?
- Lymph Node Mapping, Sentinel Lymph Node Biopsy and Technetium Tc-99m Sulfur Colloid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2009to 27 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Possible or suspicious sebaceous gland carcinoma of the eyelid
- A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis
- 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 informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants
Who cannot join
- Pregnant or nursing females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.
Read the detailed description
PRIMARY OBJECTIVES:
- Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas.
II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas.
SECONDARY OBJECTIVE:
- Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.
OUTLINE:
Patients receive technetium Tc 99m sulfur colloid intradermally (ID) and then undergo lymph node mapping and SLN biopsy.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
- Conditions
- Eyelid Sebaceous Gland Carcinoma
- Being tested
- Lymph Node Mapping, Sentinel Lymph Node Biopsy, Technetium Tc-99m Sulfur Colloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph Node MappingProcedure or surgery
Also called lymphatic mapping
Undergo lymph node mapping
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo SLN biopsy
Technetium Tc-99m Sulfur ColloidDrug
Also called Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (SLN localization and biopsy) | Experimental | Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy. Receives: Procedure: Lymph Node Mapping; Procedure: Sentinel Lymph Node Biopsy; Drug: Technetium Tc-99m Sulfur Colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel Lymph Node Positivity
Number of patients who had a positive sentinel lymph node
Measured: One year after the surgical procedure under study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study start25 Feb 2009
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eyelid Sebaceous Gland CarcinomaStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bita M Esmaeli, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832429
- Sponsor's protocol ID
- 2008-0266
- Other IDs
- NCI-2011-01097, 2008-0266
- Status last verified
- Jul 2025
- First submitted
- 29 Jan 2009
- Last updated
- 4 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
- ClinicalTrials.gov ID
- NCT00832429
- Acronym / sponsor ID
- 2008-0266
- Conditions
- Eyelid Sebaceous Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Feb 2009 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.
Detailed description
PRIMARY OBJECTIVES:
- Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas.
II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas.
SECONDARY OBJECTIVE:
- Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.
OUTLINE:
Patients receive technetium Tc 99m sulfur colloid intradermally (ID) and then undergo lymph node mapping and SLN biopsy.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (SLN localization and biopsy) | Experimental | Procedure: Lymph Node Mapping, Procedure: Sentinel Lymph Node Biopsy, Drug: Technetium Tc-99m Sulfur ColloidPatients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Possible or suspicious sebaceous gland carcinoma of the eyelid
- A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis
- 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 informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Lymph Node MappingAlso: lymphatic mappingUndergo lymph node mapping | Procedure or surgery | Diagnostic (SLN localization and biopsy) |
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo SLN biopsy | Procedure or surgery | Diagnostic (SLN localization and biopsy) |
| Technetium Tc-99m Sulfur ColloidAlso: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur ColloidGiven ID | Drug | Diagnostic (SLN localization and biopsy) |
Primary outcome
Sentinel Lymph Node Positivity
Time frame: One year after the surgical procedure under study.
Number of patients who had a positive sentinel lymph node
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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 M Esmaeli 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 2 study testing Lymph Node Mapping, Sentinel Lymph Node Biopsy and Technetium Tc-99m Sulfur Colloid in people with Eyelid Sebaceous Gland Carcinoma, 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 3 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 4 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sentinel Lymph Node Positivity (time frame: One year after the surgical procedure under study.). 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 4 Jul 2025.