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

Tracking Information

First Received Date ^ICMJE

April 11, 2007

Last Updated Date

May 6, 2008

Start Date ^ICMJE

July 2000

Estimated Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plaque tilt using intraoperative ultrasonography [ Time Frame: End of study ] [ Designated as safety issue: No ]
Local melanoma failure [ Time Frame: End of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Plaque tilt using intraoperative ultrasonography
Local melanoma failure

Change History

Complete list of historical versions of study NCT00459849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Uveal Melanoma

Intervention ^ICMJE

Procedure: Intraoperative ultrasonography

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

175

Estimated Completion Date

July 2007

Estimated Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

Ciliary melanoma

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00459849

Responsible Party

Archavan Almony, M.D., Barnes Retina Institute

Study ID Numbers ^ICMJE

HRPO# 07-0092

Study Sponsor ^ICMJE

Barnes Retina Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

J W Harbour, MD

Washington University School of Medicine

Information Provided By

Barnes Retina Institute

Verification Date

May 2008

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