Sentinel Lymph Node (SLN) Biopsy for Sebaceous Gland Carcinoma of Eyelid

• ClinicalTrials.gov Identifier: NCT00832429
• Recruitment Status: Recruiting
• First Posted: January 30, 2009
• Last Update Posted: April 14, 2020
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief Summary:

The goal of this clinical research study is to use sentinel lymph node (SLN - the lymph nodes closest to the primary tumor that are believed to be at greatest risk for spread of the disease) mapping to find SLNs and biopsy them to see if you have metastatic disease (cancer that has spread) that would otherwise have not been found.

Condition or disease	Intervention/treatment	Phase
Eye Cancer	Procedure: Lymphatic Mapping; Procedure: SLN Mapping/Biopsy; Drug: Tc99m-Sulfur colloid	Phase 2

Detailed Description:

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 Design

• 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

Arms and Interventions

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.

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: Sentinel Lymph Node Mapping; Sentinel Lymph Node Biopsy; SLN Biopsy Procedure; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Participant must be 18 years of age or over
2. Possible or suspicious sebaceous gland carcinoma of the eyelid.
3. 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.
4. 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.

Contacts and Locations

Contacts

Contact: Bita Esmaeli, MD; 713-794-1247; besmaeli@mdanderson.org

Locations

United States, Texas

University of Texas MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Bita Esmaeli, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Bita Esmaeli, MD; M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

• 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
• 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

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

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