GlioblastomaPhase 1/2NCT00250211
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
A Phase 1/2 study testing Functional MRI imaging and tomotherapy in people with Glioblastoma and Glioma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioblastoma, Glioma
- What is being tested?
- Functional MRI imaging and tomotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2005to Apr 2011
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed glioblastoma multiforme
- Ages 18-65
- Karnofsky Performance Scale (KPS) equal to or less than 70
- Minimal neurological deficit
- Eligible for concurrent temozolomide chemotherapy
Who cannot join
- Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.
- Conditions
- Glioblastoma, Glioma
- Being tested
- Functional MRI imaging and tomotherapy
- Keywords
- magnetic resonance imaging, functional, radiation therapy, temozolomide, functional imaging, concurrent chemoradiation
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI imaging and tomotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
determine tumor response and pattern of failure using functional MRI imaging
Measured: Study completion
time to disease progression
Measured: Study completion
Secondary outcomes (3)
distinguish residual tumor from treatment-related necrosis
Measured: study completion
survival
acute late toxicity of tomotherapy and hypofractionation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Bassam Abdulkarim, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250211
- Sponsor's protocol ID
- CNS-09-0027 / ethics 21780
- Status last verified
- Oct 2011
- First submitted
- 4 Nov 2005
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
- ClinicalTrials.gov ID
- NCT00250211
- Acronym / sponsor ID
- CNS-09-0027 / ethics 21780
- Conditions
- Glioblastoma, Glioma
- Keywords
- magnetic resonance imaging, functional, radiation therapy, temozolomide, functional imaging, concurrent chemoradiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Mar 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Nov 2005 (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 learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed glioblastoma multiforme
- Ages 18-65
- Karnofsky Performance Scale (KPS) equal to or less than 70
- Minimal neurological deficit
- Eligible for concurrent temozolomide chemotherapy
Key exclusion criteria (1 listed)
- Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer
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 |
|---|---|---|
| Functional MRI imaging and tomotherapy | Procedure or surgery | – |
Primary outcome
determine tumor response and pattern of failure using functional MRI imaging
Time frame: Study completion
time to disease progression
Time frame: Study completion
3 secondary outcomes
distinguish residual tumor from treatment-related necrosis
Time frame: study completion
survival
acute late toxicity of tomotherapy and hypofractionation
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 24 Feb 2016.
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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.
Bassam Abdulkarim, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Functional MRI imaging and tomotherapy in people with Glioblastoma and Glioma, run by AHS Cancer Control Alberta at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 24 Feb 2016. 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 Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
determine tumor response and pattern of failure using functional MRI imaging (time frame: Study completion). The study lists 2 primary outcomes in all. 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 24 Feb 2016.