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.
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Investigational MRI Clinical Software and Hardware
At a glance
Conditions
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.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- 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.