Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI

• Status: Completed
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach.

The primary objective is to evaluate the pharmacokinetic profile of P03277 in plasma following single intravenous injection of 0.05 mmol/kg body weight in pediatric population aged from 2 to 17 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet

Criteria

Inclusion Criteria:

• Female or male pediatric patient aged 2 to 17 years,

• 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 or musculoskeletal system (including extremities),

• Patient whose parent(s) or legal guardian having read the information, provided their consent to patient's participation in writing by dating and signing the informed consent prior to any trial related procedure being conducted,

• 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),

Exclusion Criteria:

• 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 P03277 administration,

• Patient whose preceding to P03277 administration or subsequent treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) would alter P03277 pharmacokinetic parameters,

• 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],

• Patient with history of bleeding disorder,

• Patient with known severe liver disease,

• Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),

• 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,

• Patient with electrolyte or fluid imbalance that at Investigator's judgment presents undue risk assessed within 1 month prior to P03277 administration,

• Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after P03277 administration,

• Patient who received or will receive any other contrast agent for CT and/or MRI within 1 week prior to or 1 week after P03277 administration,

• Pregnant or breast-feeding female patient [female patient with childbearing potential (who experienced menarche) must have a negative urine pregnancy test within 24 hours prior to P03277 administration and must be using medically approved contraception if sexually active].