Brain TumorsNCT00907244
Arterial Spin Labeling Perfusion Magnetic Resonance (MR) Imaging in Pediatric Brain Tumors
An observational study of Brain Tumors, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to get information regarding the usefulness and accuracy of this new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain Tumors
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2012
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients between 0-18 years who are diagnosed with primary brain tumor, undergoing MRI for clinical purpose are eligible for the study.
Who may be able to join
- Age 0-18 years
- Primary brain tumor (newly diagnosed or recurrent) with measurable disease (at least 1cm2)
Who cannot join
- Patients with cardiac pacemaker or ferrous metal foreign bodies
- Patients with medical problems contradictive to receiving MRI scans.
- Patients requiring general anesthesia or sedation for their MRI scan.
- Patients with a history of cerebrovascular disorders (stroke, moya moya) that may alter cerebral perfusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: CHP-901:Arterial Spin Labeling Perfusion MR Imaging in Pediatric Brain Tumors
The purpose of this study is to get information regarding the usefulness and accuracy of this new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors.
Read the detailed description
The purpose of this study is to get information regarding the usefulness and accuracy of this new MRI technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors. This technique can non-invasively measure the blood flow to the brain during MRI examination. Because aggressive brain tumors require new blood vessels and a high level of blood supply to support its growth, we believe the tumor blood flow measured using ASL is a reliable indicator of tumor grade. This information may be useful for doctors to make treatment decisions and to monitor patients' response to treatment.
- Conditions
- Brain Tumors
- Medical subject headings
- Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startApr 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Michael Fisher, M.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907244
- Sponsor's protocol ID
- CHP 901 ASL
- Other IDs
- 2008-4-5917
- Status last verified
- Jan 2012
- First submitted
- 20 May 2009
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHP-901:Arterial Spin Labeling Perfusion MR Imaging in Pediatric Brain Tumors
- ClinicalTrials.gov ID
- NCT00907244
- Acronym / sponsor ID
- CHP 901 ASL
- Conditions
- Brain Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Apr 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 May 2009 (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 purpose of this study is to get information regarding the usefulness and accuracy of this new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors.
Detailed description
The purpose of this study is to get information regarding the usefulness and accuracy of this new MRI technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors. This technique can non-invasively measure the blood flow to the brain during MRI examination. Because aggressive brain tumors require new blood vessels and a high level of blood supply to support its growth, we believe the tumor blood flow measured using ASL is a reliable indicator of tumor grade. This information may be useful for doctors to make treatment decisions and to monitor patients' response to treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients between 0-18 years who are diagnosed with primary brain tumor, undergoing MRI for clinical purpose are eligible for the study.
Key inclusion criteria (2 listed)
- Age 0-18 years
- Primary brain tumor (newly diagnosed or recurrent) with measurable disease (at least 1cm2)
Key exclusion criteria (4 listed)
- Patients with cardiac pacemaker or ferrous metal foreign bodies
- Patients with medical problems contradictive to receiving MRI scans.
- Patients requiring general anesthesia or sedation for their MRI scan.
- Patients with a history of cerebrovascular disorders (stroke, moya moya) that may alter cerebral perfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Oct 2012.
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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.
Michael Fisher, M.D. principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by Children's Hospital of Philadelphia at 1 site 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 2 inclusion and 4 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 29 Oct 2012. 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 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.
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.
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 29 Oct 2012.