Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
Condition: Central Nervous System Indication; Pediatric Patients; Body Indication
Intervention: P03277
Intervention description: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in the study, the patient had to meet all the following 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 or musculoskeletal system (including
             extremities),

          3. 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,

          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.

        Non-inclusion Criteria:

        Patients could not be included in the study if they presented with one or more of the
        following non-inclusion criteria:

          1. 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,

          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 PK parameters,

          3. Patient with acute or chronic renal insufficiency defined as estimated Glomerular
             Filtration Rate (eGFR) out of age-adjusted normal ranges (eGFR calculated with 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 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,

         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 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, 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.

               -  medically approved contraception methods include: female sterilization, use of
                  oral, injected or implanted hormonal methods of contraception or other forms of
                  hormonal contraception that have comparable efficacy (failure rate <1%), for
                  example hormone vaginal ring or transdermal hormone contraception, placement of
                  an Intrauterine Device (IUD) or Intrauterine System (IUS), barrier methods of
                  contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with
                  spermicidal foam/gel/film/cream/ vaginal suppository).