Central Nervous System PathologyPhase 1NCT00411931
A Pharmacokinetics Study of MultiHance in Pediatric Patients
A Phase 1 study testing Multihance in people with Central Nervous System Pathology, run by Bracco Diagnostics, Inc at 1 site in Poland.
Trial summary
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Central Nervous System Pathology
- What is being tested?
- Multihance
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 1
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female between 2 and 5 years of age
- Obtained informed consent from patient's parent or guardian
- Obtain assent when applicable according to local law
- Known or suspected disease of the central nervous system (brain or spine)
- Referred for MRI of the brain or spine requiring an injection of an MR contrast agent
Who cannot join
- Contraindications to MR examination
- Undergoing MRI in an emergency situation
- Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
- Sickle cell anemia
- Likely to undergo an invasive examination within 72 hours after administration of the investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
- Conditions
- Central Nervous System Pathology
- Being tested
- Multihance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultihanceDrug
0.5M administered as a single injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the blood PK of Multihance in patients from 2 to 5 years of age
Measured: up to 24 hours post dose
Secondary outcomes (1)
Evaluate the safety of Multihance in patients from 2 to 5 years of age
Measured: through 72 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 posted15 Dec 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System PathologyStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gianpaolo Pirovano, M. D., Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411931
- Sponsor's protocol ID
- MH 119
- Status last verified
- Jan 2008
- First submitted
- 13 Dec 2006
- Last updated
- 11 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS
- ClinicalTrials.gov ID
- NCT00411931
- Acronym / sponsor ID
- MH 119
- Conditions
- Central Nervous System Pathology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Dec 2006 (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.
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female between 2 and 5 years of age
- Obtained informed consent from patient's parent or guardian
- Obtain assent when applicable according to local law
- Known or suspected disease of the central nervous system (brain or spine)
- Referred for MRI of the brain or spine requiring an injection of an MR contrast agent
Key exclusion criteria (5 listed)
- Contraindications to MR examination
- Undergoing MRI in an emergency situation
- Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
- Sickle cell anemia
- Likely to undergo an invasive examination within 72 hours after administration of the investigational product
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 |
|---|---|---|
| Multihance0.5M administered as a single injection | Drug | – |
Primary outcome
Assess the blood PK of Multihance in patients from 2 to 5 years of age
Time frame: up to 24 hours post dose
1 secondary outcome
Evaluate the safety of Multihance in patients from 2 to 5 years of age
Time frame: through 72 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 11 Jan 2008.
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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.
Gianpaolo Pirovano, M. D. study director
Bracco Diagnostics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multihance in people with Central Nervous System Pathology, run by Bracco Diagnostics, Inc at 1 site in Poland.
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 5 inclusion and 5 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 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 the blood PK of Multihance in patients from 2 to 5 years of age (time frame: up to 24 hours post dose). 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 11 Jan 2008.