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Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid
This study is currently recruiting participants.
Study NCT00386906   Information provided by M.D. Anderson Cancer Center
First Received: October 10, 2006   Last Updated: October 6, 2009   History of Changes

October 10, 2006
October 6, 2009
May 2000
May 2014   (final data collection date for primary outcome measure)
Number of Patients with SLN Positivity in Conjunctival/eyelid Melanomas [ Time Frame: Ophthalmologic exam to check for recurrence every three months during Year 1 and every 6 months during Years 2-5. ] [ Designated as safety issue: No ]
Identify the rate of SLN positivity in patients with conjunctival/eyelid melanoma. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00386906 on ClinicalTrials.gov Archive Site
 
Identify the false negative rate of SLN biopsy in patients with conjunctival/eyelid melanoma. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]
 
Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid
Sentinel Lymph Node Localization and Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid: A Pilot Study

The goal of this clinical research study is to localize 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.

Primary Objectives:

  • Identify the rate of sentinel lymph node (SLN) positivity in conjunctival/eyelid melanomas
  • Determine the false negative rate for SLN biopsy for the same

Secondary Objective:

  • Determine the complication rate for this technique, particularly with respect to local ocular and periocular side effects as well as the risk of facial nerve damage

Patients in this study have had their conjunctival or eyelid tumor surgically removed or is scheduled to have it removed. Patients will have lymphatic mapping before their 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.

Patients will then go to the operating room and undergo intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, patients 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 patients may require further treatment after consultation with their oncologist.

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.

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

Phase I
Interventional
Diagnostic, Open Label, Single Group Assignment
  • Eye Disease
  • Melanoma
Procedure: Sentinel Lymph Node Mapping and Biopsy
Other: SLN = Sentinel Lymph Node
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
38
 
May 2014   (final data collection date for primary outcome measure)

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
  3. Ability to undergo surgery under general anesthesia
  4. A chest X-ray (CXR), liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis
  5. Participants must have a negative ultrasound of regional lymph nodes.
  6. Capable of giving written informed consent
  7. Women of childbearing potential are not eligible unless tested negative for pregnancy prior to SLN mapping and biopsy.

Exclusion Criteria: N/A

Both
18 Years and older
No
Contact: Bita Esmaeli, MD 713-792-6920
United States
 
NCT00386906
Bita Esmaeli, MD/Assoc. Professor, U.T. M.D. Anderson Cancer Center
GSP00-106
M.D. Anderson Cancer Center
 
Principal Investigator: Bita Esmaeli, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP