Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04410133
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2020-05-27
Brief Title:
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Sponsor:
Blue Earth Diagnostics
Organization:
Blue Earth Diagnostics
Study Overview
Official Title:
An Open-label Single-arm Single-dose Prospective Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography PET in Detecting Recurrent Brain Metastases After Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2023-07
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:
REVELATE
Brief Summary:
An open-label single dose single arm prospective multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography PET in detecting recurrent brain metastases after radiation therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None