Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386906
Recruitment Status : Active, not recruiting
First Posted : October 12, 2006
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.

Condition or disease Intervention/treatment Phase
Eye Disease Melanoma Procedure: Sentinel Lymph Node Mapping and Biopsy Phase 1

Detailed Description:

You have had your conjunctival or eyelid tumor surgically removed or it is scheduled to have it removed. You will have lymphatic mapping before the tumor is removed. Lymphatic mapping is when a small volume of Tc99m-Sulfur colloid is injected by an ophthalmologist after which some radiologic images are taken.

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.

You will then go to the operating room and have intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, you will go on to have complete lymph node dissection, which involves removal of all the lymph nodes around the positive SLN. Then the disease will be restaged and you may require further treatment after consultation with their oncologist.

Your medical record will be reviewed, and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease. The information collected from your medical records will include information about your sex, age, what type of cancer that you have, as well as the size of the cancer and its location.

Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious. With this technique, researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced. Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup, which is routine for conjunctival/eyelid melanoma.

Length of Study:

Your active participation on this study will be over once the biopsy is over. You will continue to be observed on study for 5 years after the biopsy.

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.

Every 6 months for the first year after the biopsy, blood (less than 1 teaspoon) will be drawn for liver function tests. You will also have a chest x-ray. You will then have these tests 1 time each year for 5 years after the biopsy.

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. The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy.

This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
Actual Study Start Date : May 2000
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Sentinel Lymph Node (SLN) Biopsy
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
Procedure: Sentinel Lymph Node Mapping and Biopsy
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Primary Outcome Measures :
  1. Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas [ Time Frame: 3 months ]
    The frequency of lymphatic drainage basins for bulbar versus palpebral conjunctiva and for nasal and the temporal quadrants estimated with 95% confidence intervals. The rate of identification of SLN evaluated with a confidence interval. The probability of positive SLN in primary conjunctival and eyelid melanoma estimated.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participants must be 18 years of age or older.
  2. Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV.
  3. A CXR, liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis.
  4. Participant must have a negative ultrasound of regional lymph nodes (i.e., within 6 weeks of study enrollment).
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386906

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Bita Esmaeli, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00386906     History of Changes
Other Study ID Numbers: GSP00-106
NCI-2012-01480 ( Registry Identifier: NCI CTRP )
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Conjunctival Melanoma
Malignant Melanoma of the Conjunctiva
Malignant Melanoma of the Eyelid
Sebaceous Cell Carcinoma
Sebaceous Cell Carcinoma of the Conjunctiva
Sebaceous Cell Carcinoma of the Eyelid
Sentinel Lymph Node
Lymphatic Mapping
Eyelid Lesion

Additional relevant MeSH terms:
Eye Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas