Clinical trial NCT01092754: Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pathological Processes
Keywords: brain, spine, liver, MRI, Pediatric
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.
timeFrame: Immediately before and immediately after Optimark dosing
Secondary outcomes:
measure: Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results.
timeFrame: through 24 hours post dose
measure: Assess the blood and urine PK levels of Optimark
timeFrame: through 10 hours post dose
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital
state: Arkansas
city: San Diego
country: United States
facility: Childrens Hospital and Health Center
state: California
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and clinics
state: Kansas
city: Shreveport
country: United States
facility: Louisiana State University Sciences Center- Shreveport
state: Louisiana
city: Detroit
country: United States
facility: Childrens Hospital of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Cardinal Glennon Childrens Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Childrens Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
affiliation: Mallinckrodt
name: Eddie Darton, MD
role: STUDY_CHAIR
References: