Investigational MRI Clinical Software and Hardware Study

This study is testing new software and hardware for MRI (Magnetic Resonance Imaging) machines. Researchers want to make sure the images produced by the MRI are good enough for doctors to use for diagnosis. Some participants will receive Gadavist 2Ml Solution for Injection, a contrast agent used to improve MRI images. This study is open to healthy volunteers and patients aged 18 to 90. If you receive Gadavist, you must have healthy kidney function (GFR ≥60 ml/min for healthy volunteers, or GFR ≥30 ml/min for patients). The main goal is to develop and confirm the usefulness of these new MRI settings over 5 years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll up to 2000 participants. It involves testing different MRI settings and, for some, receiving a contrast agent.
What's involved
You would undergo MRI scans. If contrast is administered, you would receive Gadavist 2Ml Solution for Injection. The record does not specify the number of visits or the total duration of your participation.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for the study is measured at 5 years, but it's not specified if this refers to individual participant follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05215132

Investigational MRI Clinical Software and Hardware

Active, Not Recruiting
PHASE4Ages 18–90InterventionalDiagnostic
Northwestern University
~2,000 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:MRIGadavist 2Ml Solution for Injection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Conduct clinical protocol development and validation
Measured over 5 years
Image, Body

NCT05215132

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwestern University- Feinberg School of Medicine

    Chicago, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

• 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

• 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
  • Conduct clinical protocol development and validation5 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.