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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-25

Study Completion Date

2024-08-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Eyelid Sebaceous Gland Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (SLN localization and biopsy)

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

Group Type EXPERIMENTAL

Lymph Node Mapping

Intervention Type PROCEDURE

Undergo lymph node mapping

Sentinel Lymph Node Biopsy

Intervention Type PROCEDURE

Undergo SLN biopsy

Technetium Tc-99m Sulfur Colloid

Intervention Type DRUG

Given ID

Interventions

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Lymph Node Mapping

Undergo lymph node mapping

Intervention Type PROCEDURE

Sentinel Lymph Node Biopsy

Undergo SLN biopsy

Intervention Type PROCEDURE

Technetium Tc-99m Sulfur Colloid

Given ID

Intervention Type DRUG

Other Intervention Names

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lymphatic mapping Sentinel Node Biopsy Sentinel node biopsy alone SLNB SNB Tc 99m Sulfur Colloid Tc-99m SC Technetium Tc 99m Sulfur Colloid

Eligibility Criteria

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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