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Gadoquatrane for Central Nervous System Imaging (Quanti CNS Trial)
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.
Quanti CNS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Quanti CNS Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Gadoquatrane - Approved Macrocyclic GBCA
- Group 2: Approved Macrocyclic GBCA - Gadoquatrane
- 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.
- 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
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."
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."
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."
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)."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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