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
Overview
- Phase
- Phase 2
- Intervention
- P03277
- Conditions
- Central Nervous System Indication
- Sponsor
- Guerbet
- Enrollment
- 80
- Locations
- 16
- Primary Endpoint
- Elimination Half-life
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach.
The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS contrast-enhanced MRI (CNS cohort).
Detailed Description
A population PK approach and an age-down staggered approach will be used. Patients will be recruited into 3 predefined age groups: 12-17, 7-11 and 2-6 years. The inclusions will start with the older group (Adolescents, 12-17 years), followed by Preadolescents (7-11 years) and finally Young Children (2-6 years of age).
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be included in the study, the patient had to meet all the following 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),
- •Patient affiliated to national health insurance according to local regulatory requirements.
- •Non-inclusion Criteria:
- •Patients could not be included in the study if they presented with one or more of the following non-inclusion criteria:
- •Patient planned for treatment or procedure (e.g., surgery) that would prevent obtaining the required blood samples or performing other trial procedures between the screening visit and up to 1 day after gadopiclenol administration,
- •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 PK parameters,
Exclusion Criteria
- Not provided
Arms & Interventions
CNS Cohort 2-6 years
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
Intervention: P03277
CNS Cohort 7-11 years
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
Intervention: P03277
CNS Cohort 12-17 years
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
Intervention: P03277
Body Cohort 2-6 years
Pediatric patients aged 2-6 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)
Intervention: P03277
Body Cohort 7-11 years
Pediatric patients aged 7-11 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)
Intervention: P03277
Body Cohort 12-17 years
Pediatric patients aged 12-17 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)
Intervention: P03277
Outcomes
Primary Outcomes
Elimination Half-life
Time Frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Total Clearance
Time Frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Central Volume of Distribution
Time Frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Peripheral Volume of Distribution
Time Frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Area Under the Curve
Time Frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Simulated Concentrations 10 Minutes Post-injection
Time Frame: 10 minutes post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Simulated Concentrations 20 Minutes Post-injection
Time Frame: 20 minutes post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Simulated Concentrations 30 Minutes Post-injection
Time Frame: 30 minutes post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.