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Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid

Primary Purpose

Eyelid Sebaceous Gland Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lymph Node Mapping
Sentinel Lymph Node Biopsy
Technetium Tc-99m Sulfur Colloid
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eyelid Sebaceous Gland Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Possible or suspicious sebaceous gland carcinoma of the eyelid
  • A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis
  • 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 informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants

Exclusion Criteria:

  • Pregnant or nursing females

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (SLN localization and biopsy)

Arm Description

Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.

Outcomes

Primary Outcome Measures

Rate of sentinel lymph node (SLN) positivity
Will be reported using descriptive statistics.
Rate of false negative events
Will be reported using descriptive statistics.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2009
Last Updated
June 21, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00832429
Brief Title
Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid
Official Title
Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2009 (Actual)
Primary Completion Date
October 13, 2026 (Anticipated)
Study Completion Date
October 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.
Detailed Description
PRIMARY OBJECTIVES: I. Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas. II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas. SECONDARY OBJECTIVE: I. Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid. OUTLINE: Patients receive technetium Tc 99m sulfur colloid intradermally (ID) and then undergo lymph node mapping and SLN biopsy. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Sebaceous Gland Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (SLN localization and biopsy)
Arm Type
Experimental
Arm Description
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
Intervention Type
Procedure
Intervention Name(s)
Lymph Node Mapping
Other Intervention Name(s)
lymphatic mapping
Intervention Description
Undergo lymph node mapping
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy
Other Intervention Name(s)
Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Intervention Description
Undergo SLN biopsy
Intervention Type
Drug
Intervention Name(s)
Technetium Tc-99m Sulfur Colloid
Other Intervention Name(s)
Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Intervention Description
Given ID
Primary Outcome Measure Information:
Title
Rate of sentinel lymph node (SLN) positivity
Description
Will be reported using descriptive statistics.
Time Frame
At day 1
Title
Rate of false negative events
Description
Will be reported using descriptive statistics.
Time Frame
At day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Possible or suspicious sebaceous gland carcinoma of the eyelid A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis 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 informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants Exclusion Criteria: Pregnant or nursing females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bita M Esmaeli
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid

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