Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma

May 6, 2008 updated by: Barnes Retina Institute

Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.

Study Overview

Status

Unknown

Conditions

Uveal Melanoma

Intervention / Treatment

Procedure: Intraoperative ultrasonography

Detailed Description

Episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. However, local failure has been reported in a substantial proportion of patients. Since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. Poor plaque localization is an important contributing factor to local failure. With the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. However, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. To address this question, we perform intraoperative B-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.

Study Type

Interventional

Enrollment (Anticipated)

175

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Missouri
  - St. Louis, Missouri, United States, 63110
    - Washington University in St. Louis School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

Ciliary melanoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plaque tilt using intraoperative ultrasonography Time Frame: End of study	End of study
Local melanoma failure Time Frame: End of study	End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnes Retina Institute

Investigators

Principal Investigator: J W Harbour, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Anticipated)

July 1, 2007

Study Completion (Anticipated)

July 1, 2007

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria