Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients

Study Overview
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Brief Summary
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The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.

Detailed Description
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Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age).

Official Title
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An Open-Label, Multicenter, Phase 4 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark(R) in Pediatric Patients (2-11 & 12-18 Yrs) Referred for Contrast-Enhanced MRI

Conditions
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Pathological Processes

Intervention / Treatment
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* Procedure: MRI
* Procedure: MRI
* Drug: Gadoversetamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 thru 18 years of age referred for MRI of the liver or CNS if female and of child-bearing potential, must have negative pregnancy test within 24 hours of study drug administration if applicable, agree to use medically accepted method of contraception throughout the study if necessary, patients entering the PK subgroup must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration understand the requirements of the study and provide written consent to participate, agree to abide by the study requirements Exclusion Criteria: previously entered into this study or a previous study using Optimark received investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period. (patients on a research protocol using an approved drug ar acceptable) medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance and all prescribed follow up known or suspected abnormal renal function for age or requiring dialysis during the study period pregnant or breastfeeding scheduled to undergo any contrast-enhanced examination within 7 days prior to baseline examination or during the course of this study period condition that is a contraindication to MRI (i.e., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other condition that would preclude patient proximity to a strong external magnetic field) experienced a previous hypersensitivity reaction to a gadolinium-based contrast agent recent history of hemolytic anemia, sickle cell anemia, or other hemoglobinopathy undergone a surgical procedure within one week prior to study admission or are planned to undergo a surgical procedure during study participation (central line placement is acceptable) history of significant claustrophobia weighs less than 25 lbs (11 kgs)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A: Other<br> | Procedure: MRI<br>* contrast enhanced MRI<br>* Other names: gadoversetamide;Drug: Gadoversetamide<br>* Subjects will receive a single dose of Optimark(0.1 mmol/kg)as a bolus thru a peripheral IV line at 1-2 mL/sec followed by a saline flush during their medically necessary MRI .<br>|
| Other: B: Other<br> | Procedure: MRI<br>* contrast enhanced MRI<br>* Other names: gadoversetamide;Drug: Gadoversetamide<br>* Subjects will receive a single dose of Optimark(0.1 mmol/kg)as a bolus thru a peripheral IV line at 1-2 mL/sec followed by a saline flush during their medically necessary MRI .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions. | Optimark is an MRI contrast. Efficacy measurements will be determined from images obtained without contrast (immediately before) and with contrast (immediately after). | Immediately before and immediately after Optimark dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results. |  | through 24 hours post dose | 
| Assess the blood and urine PK levels of Optimark |  | through 10 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain, spine, liver, MRI, Pediatric