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Study Summary
This trial is looking at the safety and tolerability of a new contrast agent for use in MRI scans in children.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 57 Patients • NCT04307186Trial Design
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- My asthma is stable; no major treatment changes in the last 4 weeks.I am under 18 years old and can give consent.I need a CE-MRI for a health condition and can follow the study's procedures.I do not have severe heart disease, or if I do, an MRI is considered necessary.My kidney function is below normal levels.My body weight is less than 2500 grams.I have never had a bad reaction to MRI contrast dyes.I am either male or female based on my reproductive system.I have recently experienced a sudden decrease in kidney function.My legal guardian can sign and follow the study's consent form and rules.I am using birth control and will undergo pregnancy tests as needed.I haven't had any contrast agents 3 days before or will not for 3 days after gadoquatrane.I don't plan any major treatments that could interfere with the study from the start until 24 hours after.
- Group 1: 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
Is it feasible for me to be enrolled in this research project?
"To be eligible to join this clinical investigation, candidates must have MRI contrast enhancement and their age should fall between 0-17. A maximum of one hundred individuals are being accepted into the trial."
Does this clinical trial accept individuals aged 65 or above?
"Research participants that meet the qualifications for this trial must be aged 0 to 17. Specifically, 43 studies are available for minors while 5 studies are open to adults above 65 years of age."
To what degree are patients exposed to peril when taking Gadoquatrane?
"Based on the available clinical evidence, we rate Gadoquatrane's safety at a 3 because this trial has reached Phase 3. This suggests that there is sufficient data to demonstrate both efficacy and safety."
How many healthcare facilities are carrying out this trial at present?
"Patients for this trial can be enrolled at Children's Mercy Hospital & Clinics in Kansas City, Missouri, Cincinnati Children's Hospital and Medical Center in Cincinnati, Ohio, and Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania as well as 44 other medical sites across the US."
Does this research project have any open slots for participants?
"According to the details hosted on clinicaltrials.gov, this experiment is no longer actively recruiting participants. The trial was first posted in August of 2023 and has not been updated since June 14th, 2023. While there are no current opportunities for enrolment with this study, 43 additional trials remain open to applicants at present."
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