Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01508221
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2012-01-08
Brief Title:
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
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:
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis a lesion that usually occurs at the original tumor site after radiosurgery These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring
Detailed Description:
The treatment phase of the study is 6 months Study procedures will be conducted such as history physical and neurological exam pregnancy testing for women of child bearing age and a Brain MRI Follow-up appointments will be every 3 months for 1 year at which time your participation in the study will be concluded
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