This trial is active, not recruiting.

Condition uveal melanoma
Treatment intraoperative ultrasonography
Sponsor Barnes Retina Institute
Start date July 2000
End date July 2007
Trial size 175 participants
Trial identifier NCT00459849, HRPO# 07-0092


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Plaque tilt using intraoperative ultrasonography
time frame: End of study
Local melanoma failure
time frame: End of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients with uveal melanoma treated with brachytherapy Exclusion Criteria: - Ciliary melanoma

Additional Information

Official title Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Principal investigator J W Harbour, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Barnes Retina Institute.