Pathological ProcessesPhase 4NCT01092754
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
A Phase 4 study testing MRI and Gadoversetamide in people with Pathological Processes, run by Guerbet at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pathological Processes
- What is being tested?
- MRI and Gadoversetamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2002to Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45202
University Hospitals of Cleveland
Cleveland, Ohio, 44102
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Texas Childrens Hospital
Houston, Texas, 77002
Children's Mercy Hospitals and clinics
Kansas City, Kansas, 66101
Arkansas Childrens Hospital
Little Rock, Arkansas, 72201
Miami Children's Hospital
Miami, Florida, 33011
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19092
Childrens Hospital and Health Center
San Diego, California, 92101
Louisiana State University Sciences Center- Shreveport
Shreveport, Louisiana, 71101
Cardinal Glennon Childrens Hospital
St Louis, Missouri, 63010
St. Louis Childrens Hospital
St Louis, Missouri, 63010
About this study
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
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.
Read the 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).
- Conditions
- Pathological Processes
- Being tested
- MRI, Gadoversetamide
- Keywords
- brain, spine, liver, MRI, Pediatric
- Medical subject headings
- Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Also called gadoversetamide
contrast enhanced MRI
MRIProcedure or surgery
Also called gadoversetamide
contrast enhanced MRI
GadoversetamideDrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| A: Other | Other | Not described Receives: Procedure: MRI; Drug: Gadoversetamide |
| B: Other | Other | Not described Receives: Procedure: MRI; Drug: Gadoversetamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately before and immediately after Optimark dosing
Secondary outcomes (2)
Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results.
Measured: through 24 hours post dose
Assess the blood and urine PK levels of Optimark
Measured: through 10 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMay 2002
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological ProcessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eddie Darton, MD, Study chair, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092754
- Sponsor's protocol ID
- 1177-01-597
- Status last verified
- Jul 2017
- First submitted
- 15 Mar 2010
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01092754
- Acronym / sponsor ID
- 1177-01-597
- Conditions
- Pathological Processes
- Keywords
- brain, spine, liver, MRI, Pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Other | Other | Procedure: MRI, Drug: Gadoversetamide |
| B: Other | Other | Procedure: MRI, Drug: Gadoversetamide |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: gadoversetamidecontrast enhanced MRI | Procedure or surgery | A: Other |
| MRIAlso: gadoversetamidecontrast enhanced MRI | Procedure or surgery | B: Other |
| GadoversetamideSubjects 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 . | Drug | A: Other, B: Other |
Primary outcome
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).
2 secondary outcomes
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
Assess the blood and urine PK levels of Optimark
Time frame: through 10 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddie Darton, MD study chair
Mallinckrodt
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MRI and Gadoversetamide in people with Pathological Processes, run by Guerbet at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.