Trial Information

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

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.