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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. |
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| 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. |
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| 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 ] |
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| 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:
Exclusion Criteria:
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| 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 † |
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| Information Provided By | Barnes Retina Institute | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | April 11, 2007 | ||||
| Last Updated Date | May 6, 2008 | ||||