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