Investigational MRI Clinical Software and Hardware

Phase 4

Recruiting

• Conditions: Image, Body
• Interventions: Radiation: MRI; Drug: Gadavist 2Ml Solution for Injection

• Registration Number: NCT05215132
• Lead Sponsor: Northwestern University

Brief 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.

Study Timeline

• Study Start: 2019-12-19
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• • At least 18 years of age

  • Able to complete the MR safety questionnaire.
  • Able to comprehend and provide informed consent in English.
  • When contrast is being administered: healthy volunteers with a GFR≥60 ml/min
  • When contrast is being administered: patients with a GFR ≥30 ml/min

Exclusion Criteria

• • When contrast is being administered: subjects with a GFR < 30 ml/min

  • When contrast is being administered: subjects with acute kidney injury
  • When contrast is administered, allergy to gadolinium-containing contrast media
  • Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
  • Adults unable to consent
  • Individuals who are not yet adults
  • Pregnant or breastfeeding women
  • Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient w/ Contrast	Gadavist 2Ml Solution for Injection	Patients will add 15 minutes to their SOC MRI for research purposes
Patient no contrast	MRI	Patients will add 15 minutes to their SOC MRI for research purposes
Volunteer w/ contrast	Gadavist 2Ml Solution for Injection	Volunteers undergo 1 research MRI for research purposes
Volunteer w/ contrast	MRI	Volunteers undergo 1 research MRI for research purposes
Patient w/ Contrast	MRI	Patients will add 15 minutes to their SOC MRI for research purposes
Volunteer no contrast	MRI	Volunteers undergo 1 research MRI for research purposes

Primary Outcome Measures

Name	Time	Method
Conduct clinical protocol development and validation	5 years	Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.

Secondary Outcome Measures

Name	Time	Method
Demonstrate and train	5 years	Human subjects may be scanned utilizing MRI pulse sequences in the context of a clinical assessment for demonstrating of equipment or sequence function for training of MRI technologist. The sequence will be performed by a skilled technologist with the primary goal of providing information on proper utilizing of MRI hardware and software for technologist who are training and will be possibly utilizing these technique to provided safe and effective use of MRI systems and their software.

Trial Locations

Locations (1)

Northwestern University- Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States