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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Eye Cancer

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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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Rate of SLN (sentinel lymph node) Positivity + False Negative Events

Outcome Description:

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.

Outcome Time Frame:

Every 3 months for Year 1, every 6 months Years 2-5

Safety Issue:

No

Principal Investigator

Bita Esmaeli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0266

NCT ID:

NCT00832429

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Eye Cancer
  • Sebaceous Gland Carcinoma of the Eyelid
  • Eyelid Sebaceous Gland Carcinoma
  • Cancer of the eyelid
  • Eye Cancer
  • Tumors of the Eye
  • Sentinel Lymph Node Localization and Biopsy
  • SLN
  • Metastatic Disease
  • Metastatic Cancer of the Eyelid
  • Lymphatic Mapping
  • SLN Mapping/Biopsy
  • SLN Biopsy Procedure
  • SLN Biopsy
  • Lymph Nodes
  • Tc99m-Sulfur Colloid
  • Single Photon Emission Computed Tomography
  • Computed Tomography
  • SPECT/CT
  • Carcinoma
  • Eye Neoplasms
  • Adenocarcinoma, Sebaceous

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030