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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

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.

Detailed Summary:

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 f
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: To use sentinel lymph node (SLN) mapping to find SLNs and biopsy them to verify metastatic disease otherwise not found. [ Time Frame: 6 Years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: January 29, 2009
Date Started: February 2009
Date Completion: February 2019
Last Updated: March 29, 2017
Last Verified: March 2017