Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, gadopiclenol, in pediatric patients from 2 to 17 years of age undergoing contrast-enhanced MRI

GUERBET0 sites80 target enrollmentAugust 24, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pediatric subjects from 2 to 17 years old scheduled to undergo routine gadolinium contrast enhanced Magnetic Resonance Imaging
Sponsor: GUERBET
Enrollment: 80
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

August 24, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Female or male pediatric patient aged 2 to 17 years,
•2\. Patient with known or suspected lesion(s) scheduled to undergo routine contrast\-enhanced MRI of CNS or of other organs including at least one organ among head and neck, thorax, abdomen, pelvis and musculoskeletal system (including extremities),
•3\. Patient whose parent(s) or legal guardian (where applicable) having read the information provided his/her/their consent to patient’s participation in writing by dating and signing the informed consent prior to any trial related procedure being conducted,
•4\. Patient with capacity of understanding who received age\- and maturity\-appropriate information and provided his/her assent to participate in the trial (as required by national regulations),
•5\. Patient affiliated to national health insurance according to local regulatory requirements.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•1\.Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to 1 day after gadopiclenol administration,
•2\.Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters,
•3\.Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age\-adjusted normal ranges \[eGFR must be calculated based on bedside Schwartz equation],
•4\.Patients referred for MR Angiography.
•5\.Patient with history of bleeding disorder,
•6\.Patient with known severe liver disease,
•7\.Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),
•8\.Patient with any clinically significant abnormal 12\-lead ECG that in the Investigator's opinion would affect the safety evaluation or place the patient at risk,
•9\.Patient with electrolyte or fluid imbalance that at Investigator’s judgment presents undue risk assessed within 1 month prior to gadopiclenol administration,
•10\.Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after gadopiclenol administration,