Brain TumorNCT01018329
Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma
A study testing Magnetic Resonance Imaging, Diffusion Tensor Imaging and Magnetic Resonance Spectroscopic Imaging in people with Brain Tumor, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Magnetic Resonance Imaging, Diffusion Tensor Imaging and Magnetic Resonance Spectroscopic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being treated for diagnosed with high grade glioma (WHO grade III or IV) at the University of Pennsylvania Medical Center who will be undergoing radiation therapy to the brain
- Patient or legal representative able to provide written informed consent
- Adult males and nonpregnant females
Who cannot join
- Vulnerable populations as specified (including pregnant patients, prisoners, patients with pacemakers or metallic implants)
- Patients with renal failure
- Patients with any condition considered a contraindication to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.
Read the detailed description
Detailed DescriptionOBJECTIVES:
- To develop a multimodality statistical model to act as a surrogate marker scheme of early changes in high grade glioma patients undergoing radiation therapy, using conventional MRI, MR diffusion tensor imaging, perfusion, permeability, and spectroscopic imaging while incorporating the radiation dose calculations delivered locally and the results of a clinical questionnaire into the model.
II. To assess treatment response to tumor and normal tissue changes. OUTLINE: Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6, and then 4-6 weeks after completion of radiation therapy.
- Conditions
- Brain Tumor
- Being tested
- Magnetic Resonance Imaging, Diffusion Tensor Imaging, Magnetic Resonance Spectroscopic Imaging, Dynamic Contract-Enhanced magnetic resonance imaging, Diffusion-weighted magnetic resonance imaging
- Keywords
- Adult Brain Tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging
Diffusion Tensor ImagingProcedure or surgery
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Dynamic Contract-Enhanced magnetic resonance imagingProcedure or surgery
Also called DCE-MRI
Diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6 and then 4-6 weeks after completion of radiation therapy.Patients undergo MRI imaging at baseline, weeks 1, 2, 3, 5, 6 and then 6 weeks after radiation therapy. Receives: Procedure: Magnetic Resonance Imaging; Procedure: Diffusion Tensor Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Dynamic Contract-Enhanced magnetic resonance imaging; Procedure: Diffusion-weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early brain tumor response
Secondary outcomes (1)
Early therapeutic-induced changes in normal surrounding brain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018329
- Sponsor's protocol ID
- UPCC 12309
- Status last verified
- Dec 2012
- First submitted
- 19 Nov 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy
- ClinicalTrials.gov ID
- NCT01018329
- Acronym / sponsor ID
- UPCC 12309
- Conditions
- Brain Tumor
- Keywords
- Adult Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Nov 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.
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.
Detailed description
Detailed DescriptionOBJECTIVES:
- To develop a multimodality statistical model to act as a surrogate marker scheme of early changes in high grade glioma patients undergoing radiation therapy, using conventional MRI, MR diffusion tensor imaging, perfusion, permeability, and spectroscopic imaging while incorporating the radiation dose calculations delivered locally and the results of a clinical questionnaire into the model.
II. To assess treatment response to tumor and normal tissue changes. OUTLINE: Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6, and then 4-6 weeks after completion of radiation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Procedure: Magnetic Resonance Imaging, Procedure: Diffusion Tensor Imaging, Procedure: Magnetic Resonance Spectroscopic Imaging, Procedure: Dynamic Contract-Enhanced magnetic resonance imaging, Procedure: Diffusion-weighted magnetic resonance imagingPatients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6 and then 4-6 weeks after completion of radiation therapy.Patients undergo MRI imaging at baseline, weeks 1, 2, 3, 5, 6 and then 6 weeks after radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients being treated for diagnosed with high grade glioma (WHO grade III or IV) at the University of Pennsylvania Medical Center who will be undergoing radiation therapy to the brain
- Patient or legal representative able to provide written informed consent
- Adult males and nonpregnant females
Key exclusion criteria (3 listed)
- Vulnerable populations as specified (including pregnant patients, prisoners, patients with pacemakers or metallic implants)
- Patients with renal failure
- Patients with any condition considered a contraindication to MRI
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging | Procedure or surgery | I |
| Diffusion Tensor Imaging | Procedure or surgery | I |
| Magnetic Resonance Spectroscopic ImagingAlso: 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging | Procedure or surgery | I |
| Dynamic Contract-Enhanced magnetic resonance imagingAlso: DCE-MRI | Procedure or surgery | I |
| Diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRI | Procedure or surgery | I |
Primary outcome
Early brain tumor response
1 secondary outcome
Early therapeutic-induced changes in normal surrounding brain
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 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Diffusion Tensor Imaging and Magnetic Resonance Spectroscopic Imaging in people with Brain Tumor, run by Abramson Cancer Center at Penn Medicine 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 3 inclusion and 3 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 Dec 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.
What does the primary outcome measure?
Early brain tumor response. 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 Dec 2012.