EUCTR2018-001516-30-PLActive, not recruitingPhase 1
Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, gadopiclenol, in pediatric patients from 2 to 17 years of age undergoing contrast-enhanced MRI
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GUERBET
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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