Sentinel Lymph Node (SLN) Biopsy for Sebaceous Gland Carcinoma of Eyelid
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ClinicalTrials.gov Identifier: NCT00832429 |
Recruitment Status :
Recruiting
First Posted : January 30, 2009
Last Update Posted : April 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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Eye Cancer | Procedure: Lymphatic Mapping Procedure: SLN Mapping/Biopsy Drug: Tc99m-Sulfur colloid | Phase 2 |
If you agree to take part in this study, you will come into the clinic at 2 different times for lymphatic mapping and SLN mapping/biopsy.
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.
Lymphatic mapping is a procedure in which a small amount of a radioactive substance called Tc99m-Sulfur colloid is injected into the eyelid around the tumor(s) to make the lymph nodes visible on an imaging scan. After Tc99m-Sulfur colloid is injected, you will have a single photon emission computed tomography/computed tomography (SPECT/CT) scan performed.
For the SLN biopsy procedure, you will go to the operating room and undergo SLN mapping and biopsy under general anesthesia. A small amount of Tc99m-Sulfur colloid will again be injected into the eyelid around the tumor(s), to help the doctor find any possible SLNs. If you have your tumor removed earlier, the small amount of Tc99m-Sulfur colloid will be injected into the eyelid around the area of earlier tumor site. Then you will have the SLN biopsy. To collect the SLN biopsy, the doctor will make a small incision into the tissue over the lymph nodes that have picked up the Tc99m-Sulfur colloid. The lymph nodes will then be removed and tested for signs of metastatic disease.
If the biopsy shows signs of metastatic disease, you will receive the standard of care for metastatic cancer of the eyelid. You will be separately consented for this.
Length of Study:
You will continue to be observed on study for 5 years after the biopsy. You will come to the clinic for follow-up scans and tests during this time.
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.
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. You will have a chest x-ray 1 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, as well as whenever the doctor thinks it is needed.
You will have an ultrasound of lymph nodes in the cheek and neck area 1 year after the primary tumor was removed to check for metastatic disease.
This is an investigational study. The described procedure for lymphatic mapping and biopsy is standard of care for other regions of the body. Lymphatic mapping and SLN biopsy for eyelid cancers are investigational.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid |
Actual Study Start Date : | February 2009 |
Estimated Primary Completion Date : | February 28, 2021 |
Estimated Study Completion Date : | February 28, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Lymphatic Mapping + SLN Mapping/Biopsy
SLN mapping and biopsy done in OR under general anesthesia. Injection of Tc99m-Sulfur colloid again around eyelid tumor(s) or removed tumor site(s). Lymph nodes visible from injection removed and tested for signs of metastatic disease.
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Procedure: Lymphatic Mapping
SPECT/CT scan following Tc99m-Sulfur colloid injection into eyelid tumor(s) making lymph nodes visible on imaging scan. Procedure: SLN Mapping/Biopsy SLN mapping and biopsy done in OR under general anesthesia. Injection of Tc99m-Sulfur colloid again around eyelid tumor(s) or removed tumor site(s). Lymph nodes visible from injection removed and tested for signs of metastatic disease.
Other Names:
Drug: Tc99m-Sulfur colloid On the day of surgery, 0.2-0.3 cc (0.4-0.6 mCi) of Tc99m-Sulfur colloid injected intradermally around the primary lesion approximately one hour prior to the procedure. |
- Rate of SLN (sentinel lymph node) Positivity + False Negative Events [ Time Frame: Every 3 months for Year 1, every 6 months Years 2-5 ]An ophthalmologic exam to check for recurrence of the eyelid tumor is undertaken every three months during the first year and every 6 months during years 2-5. Rate of SLN positivity and the false negative events reported using descriptive statistics.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must be 18 years of age or over
- Possible or suspicious sebaceous gland carcinoma of the eyelid.
- A CXR (chest x-ray), liver enzymes, and a head and neck 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 ICD in their language, will be utilized and completed in accordance with the MDACC policy for Consenting Non-English Speaking Participants.
Exclusion Criteria:
1) Pregnant or nursing females.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832429
Contact: Bita Esmaeli, MD | 713-794-1247 | besmaeli@mdanderson.org |
United States, Texas | |
University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Bita Esmaeli, MD |
Principal Investigator: | Bita Esmaeli, MD | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00832429 |
Other Study ID Numbers: |
2008-0266 NCI-2011-01097 ( Registry Identifier: NCI CTRP ) |
First Posted: | January 30, 2009 Key Record Dates |
Last Update Posted: | April 14, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sebaceous Gland Carcinoma of the Eyelid Eyelid Sebaceous Gland Carcinoma Cancer of the eyelid Eye Cancer Tumors of the Eye Sentinel Lymph Node Localization and Biopsy SLN Metastatic Disease Metastatic Cancer of the Eyelid |
Lymphatic Mapping SLN Mapping/Biopsy SLN Biopsy Procedure SLN Biopsy Lymph Nodes Tc99m-Sulfur Colloid Single Photon Emission Computed Tomography Computed Tomography SPECT/CT |
Carcinoma Eye Neoplasms Adenocarcinoma, Sebaceous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Eye Diseases Adenocarcinoma Neoplasms, Adnexal and Skin Appendage Technetium Tc 99m Sulfur Colloid Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |