NCT05215132

Investigational MRI Clinical Software and Hardware

Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Patients and healthy volunteers will be scanned in order to test new sequences.

Detailed description

The aims of this study are to: 1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values. 2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.

Conditions

• Image, Body

Interventions

Type	Name	Description
RADIATION	MRI	1.5T or 3T MRI scanner (Siemens Medical Systems)
DRUG	Gadavist 2Ml Solution for Injection	Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)

Timeline

• Start date: 2019-12-19
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2022-01-31
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study