Malignant GliomasNCT01549392
Imaging Study of Glioblastomas Treated With Avastin
A study testing DECT and MR spectroscopy in people with Malignant Gliomas, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malignant Gliomas
- What is being tested?
- DECT and MR spectroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of glioblastoma with clinical or radiological evidence of progression as indicated by the RANO criteria 19
- Previous radiation and temozolomide chemotherapy
- Patients must be receiving Avastin chemotherapy as second-line treatment if in the Avastin group
- Study-specific consent
Who cannot join
- Failure to meet inclusion criteria
- Pregnant or lactating patients
- Allergy to iodine or CT contrast precludes DECT component of study
- Claustrophobia precludes MR Spectroscopy component of study
- Internal metal which would preclude an MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin
This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood flow cerebral blood volume and permeability-surface area can be generated from the DECT studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.
Read the detailed description
The clinical determination of the point of tumour progression or response is difficult to determine using standard diagnostic imaging ie CT/MRI especially following previous treatment with surgery, radiation and chemotherapy. Hemorrhage, edema, inflammation and vascular necrosis.
Both MR spectroscopy and DECT have been reported as being able to define areas of recurrent tumour as opposed to treatment-related effects. We wish to investigate the correlation between MR spectroscopy and DECT in assessing tumour progression or response to Avastin in comparison with patients not receiving Avastin.
Health Canada has approved Avastin for clinical use in patients with recurrent glioblastoma who have previously received temozolomide and radiotherapy. We propose to perform a DECT scan at baseline at presumed tumour progression and again 3 months to determine the effects of tumour progression/response on blood brain barrier permeability and vascular volume. The group of 15 patients will be compared to a group of 15 patients who do not receive Avastin at recurrence involving DECT scanning and MR spectroscopy at the time of the radiological progression and 3 months later.
- Conditions
- Malignant Gliomas
- Being tested
- DECT, MR spectroscopy
- Keywords
- dynamic enhanced ct scan, mri spectroscopy, recurrent gliomas
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECTDevice
Also called 3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare
DECT at tumor progression and 3 months later
MR spectroscopyDevice
Also called MRI scanner: Siemens 3T Tim Trio, Sequences: T1W, DTI, Analysis software: Brain voyager
MR spectroscopy at tumor progression and 3 months later
| Study group | Role | What they receive |
|---|---|---|
| DECT/MR Spectroscopy +Avastin | Active comparator | -15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later Receives: Device: DECT; Device: MR spectroscopy |
| DECT/MR Spectroscopy no Avastin | Active comparator | 15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 Receives: Device: DECT; Device: MR spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Month Response
participants who had reduction of tumor size from avastin at 3 months
Measured: at 3 months after initial DECT and MR spectroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant GliomasStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Regional Cancer Program, Canada
- Responsible party
- Principal investigator, Barbara Fisher, London Health Sciences Centre
- Investigators
- Barbara J Fisher, MD, Principal investigator, London Regional Cancer Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549392
- Sponsor's protocol ID
- LRCP02
- Status last verified
- Sep 2014
- First submitted
- 17 Feb 2012
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin
- ClinicalTrials.gov ID
- NCT01549392
- Acronym / sponsor ID
- LRCP02
- Conditions
- Malignant Gliomas
- Keywords
- dynamic enhanced ct scan, mri spectroscopy, recurrent gliomas
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Regional Cancer Program, Canada
- Study start
- Feb 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood flow cerebral blood volume and permeability-surface area can be generated from the DECT studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.
Detailed description
The clinical determination of the point of tumour progression or response is difficult to determine using standard diagnostic imaging ie CT/MRI especially following previous treatment with surgery, radiation and chemotherapy. Hemorrhage, edema, inflammation and vascular necrosis.
Both MR spectroscopy and DECT have been reported as being able to define areas of recurrent tumour as opposed to treatment-related effects. We wish to investigate the correlation between MR spectroscopy and DECT in assessing tumour progression or response to Avastin in comparison with patients not receiving Avastin.
Health Canada has approved Avastin for clinical use in patients with recurrent glioblastoma who have previously received temozolomide and radiotherapy. We propose to perform a DECT scan at baseline at presumed tumour progression and again 3 months to determine the effects of tumour progression/response on blood brain barrier permeability and vascular volume. The group of 15 patients will be compared to a group of 15 patients who do not receive Avastin at recurrence involving DECT scanning and MR spectroscopy at the time of the radiological progression and 3 months later.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DECT/MR Spectroscopy +Avastin | Active comparator | Device: DECT, Device: MR spectroscopy-15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later |
| DECT/MR Spectroscopy no Avastin | Active comparator | Device: DECT, Device: MR spectroscopy15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological diagnosis of glioblastoma with clinical or radiological evidence of progression as indicated by the RANO criteria 19
- Previous radiation and temozolomide chemotherapy
- Patients must be receiving Avastin chemotherapy as second-line treatment if in the Avastin group
- Study-specific consent
Key exclusion criteria (5 listed)
- Failure to meet inclusion criteria
- Pregnant or lactating patients
- Allergy to iodine or CT contrast precludes DECT component of study
- Claustrophobia precludes MR Spectroscopy component of study
- Internal metal which would preclude an MRI scan
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 |
|---|---|---|
| DECTAlso: 3 T 64-slice CT scanner (Discovery CT750 HD, GE HealthcareDECT at tumor progression and 3 months later | Device | DECT/MR Spectroscopy +Avastin, DECT/MR Spectroscopy no Avastin |
| MR spectroscopyAlso: MRI scanner: Siemens 3T Tim Trio, Sequences: T1W, DTI, Analysis software: Brain voyagerMR spectroscopy at tumor progression and 3 months later | Device | DECT/MR Spectroscopy +Avastin, DECT/MR Spectroscopy no Avastin |
Primary outcome
3 Month Response
Time frame: at 3 months after initial DECT and MR spectroscopy
participants who had reduction of tumor size from avastin at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Barbara J Fisher, MD principal investigator
London Regional Cancer Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DECT and MR spectroscopy in people with Malignant Gliomas, run by London Health Sciences Centre 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 4 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: stopped early, as of the sponsor's last update on 15 Sep 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
3 Month Response (time frame: at 3 months after initial DECT and MR spectroscopy). 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 15 Sep 2014.