Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05134012
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2021-10-29
Brief Title:
RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW RAPID-WATER-FLOW
Sponsor:
MedTrace Pharma AS
Organization:
MedTrace Pharma AS
Study Overview
Official Title:
A Phase 3 Multicenter Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15-O-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging RAPID-WATER-FLOW
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This a Phase 3 prospective open-label multicenter study of 15-O-H2O injection for PET imaging of subjects with suspected CAD Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe Approximately 215 participants will be enrolled to account for an estimated 15 drop-out rate Screening assessments will occur prior to enrollment to confirm eligibility All participants will receive two doses of 15-O-H2O as part of a single PET imaging session one dose at rest and one during pharmacological stress with adenosine A safety follow-up phone call will occur 24 8 hrs after completion of the 15-O-H2O scan
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?:
False
Is an FDA AA801 Violation?:
None