Testing new MRI software and hardware
Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software
PHASE4 · Northwestern University · NCT05215132
This study is testing new MRI technology to see if it can produce better images for diagnosing health issues in both patients and healthy volunteers.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05215132 on ClinicalTrials.gov |
What this trial studies
This study aims to validate and develop clinical protocols for MRI by scanning patients and healthy volunteers using new sequences and settings. The goal is to ensure that the images produced are of high quality for diagnostic purposes and to establish normative values. Additionally, the study includes demonstrations and training for operators on the safe and effective use of MRI systems. Participants may receive gadolinium-based contrast to enhance imaging quality during the scans.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who can provide informed consent and have adequate kidney function.
Not a fit: Patients with severe kidney impairment, contraindications to MRI, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy and effectiveness of MRI diagnostics for various medical conditions.
How similar studies have performed: Other studies have successfully tested new MRI sequences and settings, indicating that this approach is promising and has been validated in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Northwestern University- Feinberg School of Medicine — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Emily Powell
- Email: emily.powell@northwestern.edu
- Phone: 312.695.2956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Image, Body, MRI hardware testing