Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184152
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-04
Brief Title:
CEUS vs AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Contrast Ultrasound vs Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules
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:
The study will be conducted at the following locations
1 UT Southwestern Medical Center
2 Parkland Health and Hospital System
3 University of Michigan
Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI AMRI and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules
1 UT Southwestern Medical Center
2 Parkland Health and Hospital System
3 University of Michigan
Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI AMRI and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules
Detailed Description:
Investigators will prospectively perform both abbreviated MRI and contrast-enhanced ultrasound in enrolled patients every 3-6 months Contrast-enhanced ultrasound and abbreviated MRI will preferably be done the same day although will be permitted to be completed within 30 days of each other Abbreviated MRI and contrast-enhanced ultrasound will be performed every 3-6 months until HCC development regression to LR-1 or LR-2 ie definitely or likely benign respectively or end of follow-up at 24 months post-enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None