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

• 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.
  
  

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.