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

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00832429
First received: January 29, 2009
Last updated: February 3, 2014
Last verified: February 2014

January 29, 2009
February 3, 2014
February 2009
January 2016   (final data collection date for primary outcome measure)
Rate of SLN (sentinel lymph node) Positivity + False Negative Events [ Time Frame: Every 3 months for Year 1, every 6 months Years 2-5 ] [ Designated as safety issue: No ]
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.
To use sentinel lymph node (SLN) mapping to find SLNs and biopsy them to verify metastatic disease otherwise not found. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00832429 on ClinicalTrials.gov Archive Site
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Sentinel Lymph Node (SLN) Biopsy for Sebaceous Gland Carcinoma of Eyelid
Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

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.

Study Procedures:

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.

Up to 20 participants will take part in this study. All will be enrolled at MD Anderson.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Eye Cancer
  • 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
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.
Interventions:
  • Procedure: Lymphatic Mapping
  • Procedure: SLN Mapping/Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
January 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Bita Esmaeli, MD 713-792-6920
United States
 
NCT00832429
2008-0266
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Bita Esmaeli, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP