GlioblastomaEarly Phase 1NCT02466828
qBOLD MRI of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.
A Early Phase 1 study testing Feraheme® in people with Glioblastoma and Hypoxia, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults. Despite recent diagnostic and therapeutic advances, including aggressive surgical resection and chemoradiation, the prognosis of GBM has improved only slightly over the past two decades, with median survival of approximately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Hypoxia
- What is being tested?
- Feraheme®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2015to Apr 2018
- Phase
- Early Phase 1
- 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
- Adult (>18 year old) patients with newly diagnosed GBM presenting to our centre for surgical management and post-operative chemoradiation
- Creatinine clearance > 60 ml/minute
- Able to tolerate an MR scan
- Capable of providing informed consent.
Who cannot join
- Prior brain surgery or radiation
- History of liver disease requiring liver MRI (due to accumulation of ferumoxytol in Kupffer cells which can affect liver MRI for up to 3 months)
- On more than two antihypertensive medications
- History of allergy or adverse reaction to iron supplements
- Prior treatment with ferumoxytol
- Large (>50%) hemorrhagic component in the solid enhancing part of the tumor
Show all 10Show fewer
- Need for emergency craniotomy.
- Pregnant patients
- Breast feeding
- Serum ferritin of >800 ng/mL
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Quantitative Blood Oxygenation Level Dependent (qBOLD) MR Imaging of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.
Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults. Despite recent diagnostic and therapeutic advances, including aggressive surgical resection and chemoradiation, the prognosis of GBM has improved only slightly over the past two decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM that contributes to poor outcome through multiple mechanisms such as 1) overexpression of enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM and 2) increase expression of cancer stem cells which are more resistant to radiation. Hypoxic tumour regions are associated with higher rates of progression and recurrence.
In this study the investigators will use an advanced MRI technique called qBOLD to non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron supplement, and utilize two recent technical advances not previously used in human tumours to quantitatively measure oxygenation in GBM.
Prior knowledge of hypoxia can assist in prognostication and individualization of treatment planning with special focus on hypoxic regions by targeted radiation dose or regimen modulation; consideration of more intensive chemotherapy regimens; more aggressive and targeted surgical resection and closer short-term clinical and imaging follow-ups.
Read the detailed description
We propose a study to demonstrate quantitative oxygen saturation estimation in GBM is feasible with qBOLD and it correlates with established histopathological markers of hypoxia and angiogenesis, and targeted intraoperative oxygen measurement.
All patients will undergo surgery as part of their standard treatment. By coregistering the hypoxia map on presurgical MRI we will be able to do the following:
- Obtain targeted biopsies of the hypoxic areas and none hypoxic areas and correlate them with gold standard marker of tissue hypoxia by immunohistochemistry for hypoxia induced factor-1α (HIF-1α).
- Draw Volumes of interests (VOI) over areas >0.5-cm3 (amenable to accurate intra-operative O2 measurement) with the lowest and highest oxygen saturation (SO2) values. VOIs will be then imported into the neuronavigation system (Stryker) for targeted placement of clinically approved Licox® oxygen-sensing probe (Integra NeuroSciences).
- Conditions
- Glioblastoma, Hypoxia
- Being tested
- Feraheme®
- Medical subject headings
- Glioblastoma, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feraheme®Drug
Also called ferumoxytol
Drug will be diluted in 50 cc normal saline and infused over 15-60 minutes depending on patient condition.
| Study group | Role | What they receive |
|---|---|---|
| Single patient group receiving Feraheme® | Experimental | Newly diagnosed GBM patients with no prior treatment will receive Feraheme® as MRI contrast agent Receives: Drug: Feraheme® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation in GBM with qBOLD MRI and its correlation with histological markers of tissue hypoxia and angiogenesis
Pre-operative qBOLD imaging and O2 saturation mapping will be performed in 27 newly diagnosed GBM patients and targeted biopsies will be obtained from the hypoxic and non-hypoxic regions of the tumor.
Measured: Within 8 hours after the MRI exam is complete
Secondary outcomes (1)
Oxygen saturation in GBM with qBOLD MRI and its correlation with targeted intraoperative oxygen measurement
Volumes of interest from the hypoxic and non-hypoxic regions of the tumor will be imported into the neuronavigation system (Stryker) for targeted placement of Licox® oxygen-sensing probe (Integra NeuroSciences).
Measured: Within 8 hours after the MRI exam is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2018
- Study completionApr 2018
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.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Pejman Jabehdar Maralani, MD FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466828
- Sponsor's protocol ID
- 127-2014
- Status last verified
- Apr 2018
- First submitted
- 21 Nov 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Blood Oxygenation Level Dependent (qBOLD) MR Imaging of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.
- ClinicalTrials.gov ID
- NCT02466828
- Acronym / sponsor ID
- 127-2014
- Conditions
- Glioblastoma, Hypoxia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- Mar 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 9 Jun 2015 (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.
Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults. Despite recent diagnostic and therapeutic advances, including aggressive surgical resection and chemoradiation, the prognosis of GBM has improved only slightly over the past two decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM that contributes to poor outcome through multiple mechanisms such as 1) overexpression of enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM and 2) increase expression of cancer stem cells which are more resistant to radiation. Hypoxic tumour regions are associated with higher rates of progression and recurrence.
In this study the investigators will use an advanced MRI technique called qBOLD to non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron supplement, and utilize two recent technical advances not previously used in human tumours to quantitatively measure oxygenation in GBM.
Prior knowledge of hypoxia can assist in prognostication and individualization of treatment planning with special focus on hypoxic regions by targeted radiation dose or regimen modulation; consideration of more intensive chemotherapy regimens; more aggressive and targeted surgical resection and closer short-term clinical and imaging follow-ups.
Detailed description
We propose a study to demonstrate quantitative oxygen saturation estimation in GBM is feasible with qBOLD and it correlates with established histopathological markers of hypoxia and angiogenesis, and targeted intraoperative oxygen measurement.
All patients will undergo surgery as part of their standard treatment. By coregistering the hypoxia map on presurgical MRI we will be able to do the following:
- Obtain targeted biopsies of the hypoxic areas and none hypoxic areas and correlate them with gold standard marker of tissue hypoxia by immunohistochemistry for hypoxia induced factor-1α (HIF-1α).
- Draw Volumes of interests (VOI) over areas >0.5-cm3 (amenable to accurate intra-operative O2 measurement) with the lowest and highest oxygen saturation (SO2) values. VOIs will be then imported into the neuronavigation system (Stryker) for targeted placement of clinically approved Licox® oxygen-sensing probe (Integra NeuroSciences).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single patient group receiving Feraheme® | Experimental | Drug: Feraheme®Newly diagnosed GBM patients with no prior treatment will receive Feraheme® as MRI contrast agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (>18 year old) patients with newly diagnosed GBM presenting to our centre for surgical management and post-operative chemoradiation
- Creatinine clearance > 60 ml/minute
- Able to tolerate an MR scan
- Capable of providing informed consent.
Key exclusion criteria (10 listed)
- Prior brain surgery or radiation
- History of liver disease requiring liver MRI (due to accumulation of ferumoxytol in Kupffer cells which can affect liver MRI for up to 3 months)
- On more than two antihypertensive medications
- History of allergy or adverse reaction to iron supplements
- Prior treatment with ferumoxytol
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 |
|---|---|---|
| Feraheme®Also: ferumoxytolDrug will be diluted in 50 cc normal saline and infused over 15-60 minutes depending on patient condition. | Drug | Single patient group receiving Feraheme® |
Primary outcome
Oxygen saturation in GBM with qBOLD MRI and its correlation with histological markers of tissue hypoxia and angiogenesis
Time frame: Within 8 hours after the MRI exam is complete
Pre-operative qBOLD imaging and O2 saturation mapping will be performed in 27 newly diagnosed GBM patients and targeted biopsies will be obtained from the hypoxic and non-hypoxic regions of the tumor.
1 secondary outcome
Oxygen saturation in GBM with qBOLD MRI and its correlation with targeted intraoperative oxygen measurement
Time frame: Within 8 hours after the MRI exam is complete
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 18 Apr 2018.
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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.
Pejman Jabehdar Maralani, MD FRCPC principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Feraheme® in people with Glioblastoma and Hypoxia, run by Sunnybrook Health Sciences Centre at 2 sites 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 10 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Oxygen saturation in GBM with qBOLD MRI and its correlation with histological markers of tissue hypoxia and angiogenesis (time frame: Within 8 hours after the MRI exam is complete). 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 18 Apr 2018.