Gadoquatrane for Central Nervous System Imaging
(Quanti CNS Trial)

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI. The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent. The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein. Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits. At the start or during the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * check blood pressure and heart rate * review the MRI scans obtained in the study and decide on the diagnosis * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Eligibility Criteria

Adults over 18 with suspected or known brain/spinal cord issues who need contrast-enhanced MRI scans can join. They must be able to undergo two MRIs, not have severe kidney problems, unstable asthma, recent contrast agent use, or allergies to similar agents. Women must not be pregnant/breastfeeding and follow local contraception guidelines.

Inclusion Criteria

I need an MRI with contrast for my brain or spinal cord condition.

I am 18 years old or older.

Contraceptive use by female participants should be consistent with local regulations

+1 more

Exclusion Criteria

I have had a bad reaction to certain MRI contrast dyes before.

Considered clinically unstable or has a concurrent/concomitant condition affecting image comparability

I am scheduled for a procedure that could change how my scans look.

+7 more

Participant Groups

The trial is testing gadoquatrane against standard gadolinium-based contrast agents in MRIs for detecting central nervous system problems. Participants will receive both types of contrasts via injection during separate MRI scans and will visit the doctor up to seven times within a period of 6-42 days.

2Treatment groups

Experimental Treatment

Group I: Gadoquatrane - Approved Macrocyclic GBCAExperimental Treatment4 Interventions

Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2.

Group II: Approved Macrocyclic GBCA - GadoquatraneExperimental Treatment4 Interventions

Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2.