Your session is about to expire
← Back to Search
Gadoquatrane for Central Nervous System Imaging (Quanti CNS Trial)
Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will explore if a new contrast agent, gadoquatrane, can provide better images of the brain and spine for MRI scans than what is currently used.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include allergic reactions similar to other gadolinium-based agents such as skin rash or hives; however, specific side effects for gadoquatrane are being studied and monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR
Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR
Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR
Secondary study objectives
Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by Investigator on 4PS
Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the Investigator
Number of enhancing lesions seen on combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadoquatrane (BAY1747846)
2023
Completed Phase 3
~860
Gadobutrol
2020
Completed Phase 3
~960
Gadoterate meglumine
2023
Completed Phase 3
~710
Gadoteridol
2023
Completed Phase 3
~750
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,274 Previous Clinical Trials
25,514,498 Total Patients Enrolled
7 Trials studying Contrast Enhancement in Magnetic Resonance Imaging
2,322 Patients Enrolled for Contrast Enhancement in Magnetic Resonance Imaging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need an MRI with contrast for my brain or spinal cord condition.I have had a bad reaction to certain MRI contrast dyes before.I am scheduled for a procedure that could change how my scans look.My kidney function is severely impaired.I have recently experienced a sudden decrease in kidney function.My asthma is unstable or my asthma medication has recently changed.I am 18 years old or older.I have recently had or will have a contrast agent for imaging tests.I can have 2 MRI scans with contrast for this study.
Research Study Groups:
This trial has the following groups:- Group 1: Gadoquatrane - Approved Macrocyclic GBCA
- Group 2: Approved Macrocyclic GBCA - Gadoquatrane
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger