Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, P03277, in pediatric patients from 2 to 17 years of age undergoing central nervous system contrast-enhanced MRI.

GUERBET0 sites60 target enrollmentAugust 30, 2018

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 30, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GUERBET

Eligibility Criteria

Inclusion Criteria

•1\. Female or male pediatric patient aged 2 to 17 years,
•2\. Patient scheduled to undergo routine CNS contrast\-enhanced MRI,
•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: 60
•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

Exclusion Criteria

•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 (P03277\) administration,
•2\. Patient whose preceding to gadopiclenol (P03277\) administration or subsequent treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) would alter P03277 pharmacokinetic parameters,
•3\. Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age\-adjusted normal values \[eGFR must be calculated based on bedside Schwartz equation],
•4\. Patient with history of bleeding disorder,
•5\. Patient with known severe liver disease,
•6\. Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),
•7\. 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,
•8\. Patient with electrolyte or fluid imbalance that at Investigator’s judgment presents undue risk assessed within 1 month prior to gadopiclenol (P03277\) administration,
•9\. Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after gadopiclenol (P03277\) administration,
•10\. Patient who received or will receive any other contrast agent for CT and/or MRI within 1 week prior to or 1 week after gadopiclenol (P03277\) administration,