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

July 31, 2017 updated by: Guerbet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Arkansas Childrens Hospital
    • California
      • San Diego, California, United States, 92101
        • Childrens Hospital and Health Center
    • Florida
      • Miami, Florida, United States, 33011
        • Miami Children's Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66101
        • Children's Mercy Hospitals and Clinics
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Louisiana State University Sciences Center- Shreveport
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Childrens Hospital of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63010
        • Cardinal Glennon Childrens Hospital
      • Saint Louis, Missouri, United States, 63010
        • St. Louis Childrens Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44102
        • University Hospitals of Cleveland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19092
        • The Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77002
        • Texas Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: A: Other
Procedure: MRI
contrast enhanced MRI
Other Names:
  • gadoversetamide
Drug: Gadoversetamide
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 .
OTHER: B: Other
Procedure: MRI
contrast enhanced MRI
Other Names:
  • gadoversetamide
Drug: Gadoversetamide
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 .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.
Time Frame: Immediately before and immediately after Optimark dosing
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results.
Time Frame: through 24 hours post dose
through 24 hours post dose
Assess the blood and urine PK levels of Optimark
Time Frame: through 10 hours post dose
through 10 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guerbet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Eddie Darton, MD, Mallinckrodt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2002

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2003

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1177-01-597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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