Known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging) that need to be investigated by contrast-enhanced MRI of any body region including CNS. MedDRA version: 22.1 Level: LLT Classification code 10029815 Term: Nuclear magnetic resonance imaging System Organ Class: 100000004848 MedDRA version: 22.1 Level: LLT Classification code 10058644 Term: Nuclear magnetic resonance imaging whole body System Organ Class: 100000004848
Conditions
Interventions
Product Name: gadopiclenol
Product Code: P03277
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadopiclenol
CAS Number: 933983-75-6
Current Sponsor code: P03277, G03277
Concentratio
Sponsors
Guerbet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as =37 completed weeks of amenorrhea. 2. Patient with known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging, scheduled to undergo contrast-enhanced MRI of any body region including CNS. 3. Patient whose parent(s) or legal guardian (where applicable) having read the information has/have provided his/her/their consent to patient’s participation in writing by dating and signing the informed consent form prior to any trial related procedure being conducted. 4. 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: 50 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 one 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 value calculated based on bedside Schwartz equation by the central laboratory. 4. Patient presenting with known class III/IV congestive heart failure according to the Modified Ross Heart Failure Classification in Children. 5. Patient with history of bleeding disorder. 6. Patient with known severe liver disease. 7. Patient with known cardiac arrhythmia (e.g., heart rhythm anomalies, long QT syndrome). 8. Patient with electrolyte or fluid imbalance that at Investigator’s judgment presents undue risk assessed within one month prior to gadopiclenol administration. 9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration. 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration. 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker). 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents. 13. Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based). 14. Patient with known contraindication(s) to the use of any gadolinium-based contrast agent (GBCA). 15. Patient with anticipated, current or past condition (medical with particular attention to prematurity, psychological, social or geographical) that would compromise the patient’s safety or her/his ability to participate to the whole trial. 16. 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. 17. Patient having participated in a clinical trial and having received any investigational product within one week prior to or planned within one week after gadopiclenol administration. 18. Patient previously included in this trial. 19. 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 up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).;Secondary Objective: 1. To evaluate the safety of gadopiclenol (clinical and biological) up to 3 months following single administration. 2. To evaluate the efficacy of gadopiclenol-enhanced MRI by body region (CNS, vessels and pool of others) as assessed by on-site Investigator.;Primary end point(s): Gadopiclenol pharmacokinetics in plasma for pediatric patients aged up to 23 months (inclusive) will be assessed based on the following pharmacokinetic parameters determined from the population PK model: o Simulated concentrations at 10, 20 and 30 minutes post injection, o Area Under the Curve, o Elimination half-life, o Total clearance, o Volume of distribution.;Timepoint(s) of evaluation of this end point: 3 blood samples will be collected per patient (one sample will be obtained during the 10-60 minutes time window, the second sample will be obtained during the 2.0-4.0 hours’ time window and the third sample will be obtained during the 6.0-8.0 hours’ time window post-injection) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following clinical and biological safety parameters/examinations will be measured/performed: o Physical examination at visits 1, 2 (if applicable), 3, 4 and 5 including examination of general appearance, skin (including extremities), neck (including thyroid), eyes, abdomen, back, lymph nodes, peripheral vascular and neurological examination and other (any other observed abnormalities). o Vital signs (temperature, blood pressure, pulse rate and peripheral oxygen saturation (SpO2)) at 3 time points: prior to IMP injection, 10-60 min and 1 day after IMP injection. o Safety laboratory variables centrally analyzed (biochemistry and hematology) from blood samples collected prior to and 1 day after IMP injection, o Estimated glomerular filtration rate (eGFR) centrally calculated based on the bedside Schwartz equation prior to and 1 day after IMP injection, o Tolerance at the injection site at 3 time points: during injection, 10-60 min and 1 day after IMP injection, o Adverse events (AE) occurring from the beginning of patient’s participation in the trial (Informed Consent Form signature) until the end of the participation. o Clinical examination for active detection of Nephrogenic Systemic Fibrosis (NSF) at 3-month follow-up safety visit. In case of suspicion of NSF a deep skin biopsy will be performed. Efficacy will be assessed by on-site radiologist for both pre-contrast (Pre) and pre+post contrast (Paired) images, assessments will be performed for the primary anatomical area to be evaluated based on following parameters: o Technical adequacy for diagnosis using a 4-point scale: non diagnostic (reasons to be provided), poor, fair and good. o Assessment of overall contrast quality using a 5-point scale: 1= None (for example, in case of a non-enhancing lesion), 2= Poor, 3= Moderate, 4= Good, 5= Excellent. o Number and location of lesions/abnormal vessels, the largest diameter (lesions only) of three most representative lesions/abnormal vessels w | — |
Countries
Bulgaria, Hungary, Poland, United States
Contacts
Public ContactGlobal RegulatoryAffairs Pharmacist
Guerbet
Outcome results
None listed