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Gadoquatrane for Central Nervous System Imaging (Quanti CNS Trial)
Phase 3
Recruiting
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
Quanti CNS 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.Check my eligibility
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.See study design
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.
Quanti CNS 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreQuanti CNS 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)
2020
Completed Phase 2
~60
Gadobutrol
2020
Completed Phase 3
~250
Gadoteridol
2015
Completed Early Phase 1
~40
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,482 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare centers are participating in the trial?
"91 medical centres are participating in the clinical trial, such as University of California Irvine Medical Center in Orange, University of Connecticut Health Center in Farmington and Northwestern Memorial Hospital in Chicago. Other locations abound."
Answered by AI
Is enrollment active for this clinical trial?
"The latest edit to the clinicaltrials.gov page indicates that this trial, which was initially posted on July 26th 2023, is no longer seeking patients. However, there are 3 other related studies presently recruiting participants for their research."
Answered by AI
Are there any known safety risks associated with Gadoquatrane - Approved Macrocyclic GBCA?
"Our analysts at Power evaluated the safety of Gadoquatrane - Approved Macrocyclic GBCA to be a 3 due to prior clinical evidence demonstrating efficacy and multiple studies confirming its security."
Answered by AI
What aim is this clinical research endeavoring to achieve?
"This trial's primary outcome - evaluated over a one-day period - is the delineation of visualization parameters assessed by independent, blinded evaluations of unenhanced and combined pre-and post-gadolinium MRI scans. Secondary outcomes include visual parameter morphology evaluation on a three point scale as well as sensitivity for detection of lesions through both gadolinium and macrocyclic GBCA (Gadolinium Based Contrast Agent) based MRIs with BICR (Blinded Independent Central Read)."
Answered by AI
Who else is applying?
What site did they apply to?
Halo Diagnostics
What portion of applicants met pre-screening criteria?
Did not meet criteria
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