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Contrast Agent
Gadopiclenol for Pediatric Disorders
Phase 2
Recruiting
Led By Donna R Roberts, MD
Research Sponsored by Guerbet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a total of 3 blood samples per patient will be taken post-injection for pk analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Awards & highlights
Study Summary
This trial tests how a drug affects the body in babies up to 23 months old, given intravenously before a MRI.
Who is the study for?
This trial is for children under 2 years old, including newborns and preterm infants past the neonatal period, who need a contrast-enhanced MRI scan due to suspected abnormalities. Kids with severe allergies, recent or upcoming significant medical procedures, renal insufficiency, recent chemotherapy changes, or exposure to other contrast agents are excluded.Check my eligibility
What is being tested?
The study tests gadopiclenol's safety and how it moves through the body (pharmacokinetics) in kids up to 23 months old needing an MRI. Each child gets one dose of gadopiclenol before their scan. Researchers will monitor blood levels using a population pharmacokinetic approach.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include reactions similar to those seen with other MRI contrast agents like mild pain at injection site, nausea or allergic reactions. Close monitoring during the trial aims to identify any adverse effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a total of 3 blood samples per patient will be taken post-injection for pk analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 3 blood samples per patient will be taken post-injection for pk analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Curve
Elimination half-life
Simulated concentrations at 10 minutes post injection
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Age Group 3: patients aged from birth to 27 days (term newborns)Experimental Treatment1 Intervention
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Group II: Age Group 2: patients aged 28 days to less than 3 monthsExperimental Treatment1 Intervention
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Group III: Age Group 1: patients aged 3 to 23 monthsExperimental Treatment1 Intervention
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
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Who is running the clinical trial?
GuerbetLead Sponsor
68 Previous Clinical Trials
93,672 Total Patients Enrolled
Donna R Roberts, MDPrincipal InvestigatorMedical University of South Carolina, Division of Neuroradiology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have abnormal areas seen in previous scans and will have a contrast MRI.My kidney function is not normal according to a specific test.I have no treatments planned that would stop me from giving blood samples or doing trial tasks up to a day after getting gadopiclenol.I am receiving treatments that could affect how a specific contrast agent works in my body.I will not have any other contrast agents for scans within a week before or after getting gadopiclenol.My chemotherapy type or dose is changing around the time I receive gadopiclenol.I am a child aged 0 to 23 months, or I was born at term if older.
Research Study Groups:
This trial has the following groups:- Group 1: Age Group 1: patients aged 3 to 23 months
- Group 2: Age Group 2: patients aged 28 days to less than 3 months
- Group 3: Age Group 3: patients aged from birth to 27 days (term newborns)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there still vacancies to participate in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this experiment has been recruiting since September 21st 2022 and is still ongoing with the last update taking place on October 21st 2022. The research team are currently seeking 50 participants from two separate sites for their study."
Answered by AI
What is the scale of participation in this trial?
"Affirmative, clinicaltrials.gov's information indicates that this experiment is still recruiting individuals. This initiative began on September 21st 2022 and was recently edited on October 21st 2022. For the study to be successful, 50 people must enroll from two different sites."
Answered by AI
What risks do people in Age Group 1: patients aged 3 to 23 months face?
"Given the Phase 2 trial status of this medication, with some safety data but none regarding efficacy, our team at Power rated its safety for Age Group 1 (3 to 23 months) a score of two."
Answered by AI
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