Study to evaluate the safety, efficacy of gadopiclenol and how this drug is absorbed, distributed, metabolized, and eliminated from the body in children less than 2 years.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

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.
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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