Pediatric subjects from 2 to 17 years old scheduled to undergo routine gadolinium contrast enhanced Magnetic Resonance Imaging of Central Nervous System MedDRA version: 21.1 Level: PT Classification code 10029817 Term: Nuclear magnetic resonance imaging brain System Organ Class: 10022891 - Investigations MedDRA version: 21.1 Level: PT Classification code 10072232 Term: Nuclear magnetic resonance imaging spinal System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Code: gadopiclenol(form.G03277.066 &G03277.100)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadopiclenol
CAS Number: 933983-75-6
Current Sponsor code: P03277
Concentration
Sponsors
GUERBET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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, 11.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 administration, 12.Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 13.Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents, 14.Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based), 15.Patient with known contraindication(s) to the use of any gadolinium based contrast agent (GBCA), 16.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 gadopiclenol administration and must be using medically approved contraception* if sexually active], 17.Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate to the whole trial, 18.Patient unlikely to comply with the protocol, e.g., uncooperative attitude of parent(s) or legal guardian (where applicable), inability to return for follow-up visits and unlikelihood of completing the trial, 19.Having participated in a clinical trial and having received any investigational product within 7 days prior to gadopiclenol administration or planned during the trial, 20.Patient previously included in this trial, 21.Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetic profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing central nervous system (CNS) contrast-enhanced MRI (CNS cohort).;Secondary Objective: 1. To evaluate safety (clinical and biological) up to 3 months following single administration in both CNS and Body cohorts 2. To evaluate urinary excretion of gadopiclenol quantitatively up to 8 hours and in subsequent urine samples collected up to 3 months following single administration in both CNS and Body cohorts (or exceptionally up to 4 months if collection is delayed due to the COVID-19 pandemic). 3. To evaluate efficacy of gadopiclenol -enhanced MRI for CNS and body as assessed by on-site Investigator.;Primary end point(s): Gadopiclenol pharmacokinetics in plasma will be assessed in the CNS cohort both by age group and overall based on following pharmacokinetic parameters determined from the population PK model: • Simulated concentrations at 10, 20 and 30 minutes post injection • Area Under the Curve, • Elimination half-life, • Total clearance, • Volume of distribution. ;Timepoint(s) of evaluation of this end point: The start of administration is set as time point 0 (T0), and blood samples will be collected during four time windows as 1 to 20 min, 30 to 45 min, 2.0 to 3.0 hours and 7.0 to 8.0 hours post-injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary criteria will be assessed in both CNS and Body cohorts. Clinical, biological and ECG safety data • Vital signs (temperature, systolic and diastolic blood pressure, pulse rate and pulse oximetry), prior to IMP injection, 30-90 min after and 1 day after IMP injection, Blood pressure and pulse rate will be measured after a rest for at least 5 minutes in supine position. Blood pressure will not be measured on the arm used for the injection. Blood oxygen saturation SpO2 (pulse oximetry) will be measured using a transcutaneous non-invasive light emitter. • 12-lead ECG recorded prior to IMP injection, 30-90 min after and 1 day after IMP injection. o Heart rate o Intervals: RR, PR, QRS, QT [corrected QT (QTc) will be calculated according to Fridericia and Bazett methods] o ST segments, T-wave morphology, U-wave o Global morphology ECG will be recorded after a rest for at least 5 minutes in supine position. A notable QTc change is defined as a QTc (Fridericia's or Bazett's) interval > 450 ms for males and females or an increase of >30 ms from baseline. All ECGs changes considered as abnormal and clinically significant according to Investigator's judgment will be reported as AEs. • Safety laboratory variables centrally analyzed (hematology and biochemistry) from blood samples collected prior to and 1 day after IMP injection: o Hematology: red blood cells (RBCs), white blood cells (WBCs) counts: neutrophils, eosinophils, basophils, lymphocytes and monocytes, platelet count, hemoglobin, hematocrit, mean red blood cells volume (MCV); o Biochemistry: sodium, potassium, chloride, glucose, blood urea nitrogen (BUN), creatinine, total protein, calcium, phosphorus, total bilirubin, conjugated bilirubin, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, lactate dehydrogenase (LDH), PT (prothrombin time) / INR (International Normalised Ratio); • Estimated glomerular filtration rate (eGFR) centrally calculated b | — |
Countries
Bulgaria, Hungary, Poland, Slovakia, Ukraine
Contacts
Public ContactRegulatory Affairs Pharmacist
GUERBET
Outcome results
None listed