Glioblastoma MultiformeNCT00589095
Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities
An observational study of Glioblastoma Multiforme, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- dynamic contrast enhanced magnetic resonance imaging
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the Yale Brain Tumor Center for management of glioblastome multiforme
Who may be able to join
- The presence of a primary brain tumor that cannot be completely resected that requires radiation therapy with or without chemotherapy.
Who cannot join
- Patients who do not have a primary brain tumor or who are unable to tolerate the environment of the MRI scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be correlated with histopathologic findings and clinical responses to radiation therapy with or without chemotherapy.
- Conditions
- Glioblastoma Multiforme
- Being tested
- dynamic contrast enhanced magnetic resonance imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic contrast enhanced magnetic resonance imagingOther
Also called Omniscan
dynamic contrast enhanced MRI using contrast agent gadodiamide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: dynamic contrast enhanced magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV)
Measured: Upon completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Knisely, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589095
- Sponsor's protocol ID
- 0606001531
- Status last verified
- Jul 2014
- First submitted
- 2 Jan 2008
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities
- ClinicalTrials.gov ID
- NCT00589095
- Acronym / sponsor ID
- 0606001531
- Conditions
- Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Jan 2008 (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 determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be correlated with histopathologic findings and clinical responses to radiation therapy with or without chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: dynamic contrast enhanced magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Yale Brain Tumor Center for management of glioblastome multiforme
Key inclusion criteria (1 listed)
- The presence of a primary brain tumor that cannot be completely resected that requires radiation therapy with or without chemotherapy.
Key exclusion criteria (1 listed)
- Patients who do not have a primary brain tumor or who are unable to tolerate the environment of the MRI scanner
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 |
|---|---|---|
| dynamic contrast enhanced magnetic resonance imagingAlso: Omniscandynamic contrast enhanced MRI using contrast agent gadodiamide | Other | 1 |
Primary outcome
To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV)
Time frame: Upon completion of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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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.
Jonathan Knisely, M.D. principal investigator
Yale University
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 Glioblastoma Multiforme, run by Yale University 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Jul 2014. 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 was stopped early. Results are not available in the source record.
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?
To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV) (time frame: Upon completion of study). 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 2 Jul 2014.