Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-30 @ 4:08 AM
Study NCT ID:
NCT06797193
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension
Status:
RECRUITING
Status Verified Date:
2025-12
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 clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique works in identifying portal hypertension (PH). An ultrasound takes pictures of the inside of the body by bouncing sound waves off organs. PH is high blood pressure in the vein that carries blood to the liver from the stomach, small and large intestines, spleen, pancreas, and gallbladder. The complications associated with PH are clear only after severe liver dysfunction or liver cirrhosis develops and are accompanied by relatively high mortality rates (20-70% mortality within 2 years). Thus, identifying PH earlier is beneficial. The hepatic venous pressure gradient (HVPG) obtained using an invasive catheterization procedure remains the standard for assessing PH. However, using this invasive procedure to assess PH prevents frequent pressure monitoring. Thus, a noninvasive technique to estimate PH is beneficial not only for diagnosis but also for monitoring treatment and disease progression. The SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate pressure with an ultrasound contrast agent. A noninvasive technique using an ultrasound with subharmonic imaging and the SHAPE technique may work in identifying PH.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate if SHAPE with perflutren lipid microspheres (Definity) microbubbles identifies patients with clinically significant PH.
II. To evaluate if addition of subharmonic imaging-based perfusion parameters derived from time intensity curves and shear wave elastography (SWE) measurements increase the diagnostic confidence of detecting PH.
OUTLINE:
Patients receive Definity intravenously (IV) once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.
After completion of study intervention, patients are followed up for 30 minutes.
I. To evaluate if SHAPE with perflutren lipid microspheres (Definity) microbubbles identifies patients with clinically significant PH.
II. To evaluate if addition of subharmonic imaging-based perfusion parameters derived from time intensity curves and shear wave elastography (SWE) measurements increase the diagnostic confidence of detecting PH.
OUTLINE:
Patients receive Definity intravenously (IV) once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.
After completion of study intervention, patients are followed up for 30 minutes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: