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

This study is ongoing, but not recruiting participants.
Information provided by Barnes Retina Institute

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Descriptive Information Fields
Brief Title  Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Official Title  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  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  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 ]
Secondary Outcome Measure 
Condition  Uveal Melanoma
Intervention  Procedure: Intraoperative ultrasonography
MEDLINE PMIDs 8414414,   3310986,   2710530,   8635107
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  175
Start Date  July 2000
Completion Date July 2007
Eligibility Criteria 

Inclusion Criteria:

  • All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

  • Ciliary melanoma
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00459849
Organization ID HRPO# 07-0092
Secondary IDs ††
Study Sponsor  Barnes Retina Institute
Collaborators ††
Investigators 
Principal Investigator:     J W Harbour, MD     Washington University School of Medicine    
Information Provided By Barnes Retina Institute
Verification Date May 2008
First Received Date  April 11, 2007
Last Updated Date May 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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