Trial record 2 of 87 for:    Open Studies | "Eye Neoplasms"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00832429
First received: January 29, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Eye Cancer
Procedure: Lymphatic Mapping
Procedure: SLN Mapping/Biopsy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Rate of SLN (sentinel lymph node) Positivity + False Negative Events [ Time Frame: Every 3 months for Year 1, every 6 months Years 2-5 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lymphatic Mapping + SLN Mapping/Biopsy
SLN mapping and biopsy done in OR under general anesthesia. Injection of Tc99m-Sulfur colloid again around eyelid tumor(s) or removed tumor site(s). Lymph nodes visible from injection removed and tested for signs of metastatic disease.
Procedure: Lymphatic Mapping
SPECT/CT scan following Tc99m-Sulfur colloid injection into eyelid tumor(s) making lymph nodes visible on imaging scan.
Procedure: SLN Mapping/Biopsy
SLN mapping and biopsy done in OR under general anesthesia. Injection of Tc99m-Sulfur colloid again around eyelid tumor(s) or removed tumor site(s). Lymph nodes visible from injection removed and tested for signs of metastatic disease.
Other Names:
  • Sentinel Lymph Node Mapping
  • Sentinel Lymph Node Biopsy
  • SLN Biopsy Procedure

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832429

Contacts
Contact: Bita Esmaeli, MD 713-792-6920

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Bita Esmaeli, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bita Esmaeli, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00832429     History of Changes
Other Study ID Numbers: 2008-0266, NCI-2011-01097
Study First Received: January 29, 2009
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Eye Cancer
Tumors of the Eye
Sebaceous Gland Carcinoma of the Eyelid
Eyelid Sebaceous Gland Carcinoma
Cancer of the eyelid
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

Additional relevant MeSH terms:
Eye Neoplasms
Carcinoma
Adenocarcinoma, Sebaceous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Eye Diseases
Adenocarcinoma
Neoplasms, Adnexal and Skin Appendage
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014