EUCTR2018-001516-30-SK
Active, not recruiting
Phase 1
Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, gadopiclenol, in pediatric patients from 2 to 17 years of ageundergoing contrast-enhanced MRI.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GUERBET
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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,
Outcomes
Primary Outcomes
Not specified
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