Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI

Recruiting

• Conditions: Prostate Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06315595
• Lead Sponsor: Mayo Clinic

Brief Summary

This study evaluates if technical improvements in MRI can be used to provide improved performance contrast-enhanced MRI as used for angiography and perfusion as well as in non-contrast MRI.

Detailed Description

PRIMARY OBJECTIVE:

I. To study how a variety of technological approaches in MRI can be used to provide improved performance contrast-enhanced MR imaging as used for angiography and perfusion as well as in MR image acquisition without the use of contrast material.

OUTLINE: This is an observational study.

Participants undergo a non-contrast MRI on study and may optionally undergo a second non-contrast MRI on study. Participants may also undergo blood sample collection on study.

Study Timeline

• Study Start: 2015-09-30
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2030-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adults

Exclusion Criteria

• Standard exclusion criteria for clinical MRI; e.g. cardiac pacemaker, claustrophobia, an implanted device that has been determined to be MR conditional at 1.5T but not at 3T, anticipated considerable susceptibility artifact from hip prosthesis, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (MRI with contrast)	Non-Interventional Study	Participants receive gadolinium based MR contrast agent IV and undergo a MRI on study. Participants may also undergo blood sample collection on study.
Group 3 (MRIs with contrast)	Non-Interventional Study	Participants receive gadolinium based MR contrast agent IV and undergo up to two MRIs on study. Participants may also undergo blood sample collection on study.
Group 1 (MRI)	Non-Interventional Study	Participants undergo MRI on study. Participants may also undergo blood sample collection on study.

Primary Outcome Measures

Name	Time	Method
Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion	Baseline (at enrollment); possible second scan at a later date	Assessed by comparison of two images made from the raw data set but reconstructed using the standard vs. an alternative algorithm (to be determined during study). Data will be tabulated and analyzed statistically.

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States