Clinical trial

Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

Name

2008-0266

Description

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.

Trial arms

Trial start

2009-02-25

Estimated PCD

2026-10-13

Trial end

2026-10-13

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Lymph Node Mapping

Undergo lymph node mapping

Arms:

Diagnostic (SLN localization and biopsy)

Other names:

lymphatic mapping

Sentinel Lymph Node Biopsy

Undergo SLN biopsy

Arms:

Diagnostic (SLN localization and biopsy)

Other names:

Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Technetium Tc-99m Sulfur Colloid

Given ID

Arms:

Diagnostic (SLN localization and biopsy)

Other names:

Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

Size

Primary endpoint

Rate of sentinel lymph node (SLN) positivity

At day 1

Rate of false negative events

At day 1

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2024-06-10

1 organization

1 product

1 indication

Organization

M.D. Anderson Cancer Center

Product

Technetium Tc-99m Sulfur Colloid

Indication

Eyelid Sebaceous Gland Carcinoma