Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459849
Status:
UNKNOWN
Last Update Posted:
2008-05-09
First Post:
2007-04-11
Brief Title:
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Sponsor:
Barnes Retina Institute
Organization:
Barnes Retina Institute
Study Overview
Official Title:
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None