GliomaNCT02919865
MR Perfusion Methods in Patients With Suspected Recurrent High Grade Gliomas
A study testing MR perfusion imaging in people with Glioma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Radiation therapy is an important adjunct in the treatment of patients with glioma, although a common side effect is radiation-induced injury of brain parenchyma. Unfortunately, conventional MRI is not accurate in differentiating radiation-induced brain injury from recurrent tumour, both of which may demonstrate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- MR perfusion imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 13 Dec 2017to 3 Aug 2021
- 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 enrolled must have:
- Had a diagnosis of high grade glioma and had received chemoradiation
- Developed a new lesion or an increase size of their treated lesion on follow-up MRI (either on post contrast T1W images or on FLAIR)
- Karnofsky performance status (kps) score >70 (potential candidate for reresection of stereotactic radiation)
Who cannot join
- Patients under 18 years of age
- Pregnant patients (for women of child bearing potential - a negative serum beta HCGT is required).
- Known or suspected allergies to gadolinium-based contrast agents.
- Patients with chronic or acute renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), including acute renal insufficiency of any severity due to hepatorenal syndrome or in the perioperative liver transplantation period.
- General contraindications to MRI such as pacemaker or ferromagnetic implants.
- Severe cardiovascular disease
- Intractable seizures while on adequate anticonvulsant therapy (more than one seizure per month for the past 2 months)
- Sickle-cell anaemia or other known hemoglobinopathies, or other forms of haemolytic anaemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of MR Perfusion Without and With Gadolinium at 3T in the Diagnosis of Patients With Suspected Recurrent High Grade Gliomas
Radiation therapy is an important adjunct in the treatment of patients with glioma, although a common side effect is radiation-induced injury of brain parenchyma. Unfortunately, conventional MRI is not accurate in differentiating radiation-induced brain injury from recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI can be performed with an injection of exogenous contrast using dynamic contrast enhancement (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be performed without contrast injection using arterial spin labeling (ASL) or intravoxel incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted contrast enhancement (DSC) perfusion is the most common technique used in clinical practice but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based techniques in differentiating recurrent tumour from radiation-induced brain injury in patients with known high grade glioma. The investigators will compare the accuracy of IVIM, ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI.
Read the detailed description
The aim of this study is to evaluate the diagnostic accuracy of different MR perfusion methods in differentiating recurrent tumour from radiation-induced brain injury in patients with high grade gliomas. The investigators will evaluate perfusion methods which do not use an exogenous agent (ASL, IVIM) and methods which use gadolinium as a contrast agent (DSC-MRI, DCE-MRI).
A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI. The first T1 mapping method uses a Lock-Locker inversion-recovery acquisition (MOLLI) that measures apparent T1 (T1*). The second T1 mapping method uses a single-point, saturation-recovery acquisition that measures true T1 SMART1Map.
This study is a prospective study which will involve 50 patients.
Patients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study. Informed consent by the patient or a legal guardian or authorized representative of the patient will be obtained before enrollment.
Following enrollment, MR perfusion imaging (ASL, IVIM, DSC and DCE perfusion sequences) will be performed in addition to the routine neuronavigational sequence obtained fror re-operative/ therapy planning.
Following this MR examination, the patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon. The location of the biopsy will be saved intraoperatively which will allow colocalization of histopathology with imaging data. Histopathological analysis will be performed by the neuropathologist, yielding a visual quantitative estimate of percent viable tumour and radiation necrosis within the obtained specimen.
All patients, including those who do not go to surgery, will undergo clinical followup and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who did not undergo surgery.
Following a routine clinical MR examination, patients with a new lesion or an enlarging lesion will be seen by the radiation oncologist or neurosurgeon. They will be recruited by a research nurse who will ask if they are willing to participate in the research study. If the patient agrees to participate, the investigators will add perfusion sequences in addition to the clinical MR exam for treatment planning (stereotactic radiation or reresection). The MR exam performed for clinical and research purposes will last less than 45 minutes. Following surgery, the investigators will correlate pathological findings with perfusion and diffusion parameters. If the patient does not undergo surgery, we will use clinical examination and serial MRIs (including perfusion imaging) to determine if the index lesion is more likely to represent radiation necrosis or tumor progression. The investigators will follow the patient clinically for 2 years after the time of progression to determine overall survival.
Patients with high grade gliomas are followed routinely with serial MRIs. The patients with progressive enlarging lesions will be seen by the treating oncologist or neurosurgeon.
They will electronically put in a request for another MR exam which is needed clinically for surgical planning and/or follow-up with advanced MR imaging as per standard of care.
When the patient comes to radiology for their exam, they will be asked to participate in the study by the radiologist and/or the research nurse (if this breaches patient confidentiality, we can put the radiologist as the person getting consent since he is involved in patient care). If the patient agrees to participate, the study will be performed according to the study MR protocol. If not, a standard MRI as per routine clinical practice will be performed. The investigators do not intend to recruit patients who are unable to give consent themselves since patients have to have a good Karnofsky score as an inclusion criteria in this study.
- Conditions
- Glioma
- Being tested
- MR perfusion imaging
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR perfusion imagingDevice
MR perfusion imaging will be performed in addition to the routine neuronavigational sequence obtained from re-operative/therapy planning.
Following MR examination, patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon.
All patients, including those who do not go to surgery, will undergo clinical follow-up and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who do not undergo surgery.
| Study group | Role | What they receive |
|---|---|---|
| MRI perfusion imaging | Other | Patients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study. Receives: Device: MR perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the Receiver Operating Characteristic (ROC) curve
Estimate the Receiver Operating Characteristic (ROC) curve for the assessment of the diagnostic accuracy of f, CBF, CBV, Cp and Ktrans, obtained from different MR perfusion acquisition methods for distinguishing recurrent tumour from radiation necrosis.
Measured: up to 22 months
Secondary outcomes (1)
Different T1 mapping methods used for DCE-MRI will be compared to the current gold standard
Different T1 mapping methods used for DCE-MRI (MOLLI that measures apparent T1 and SMARTMap that measures true T1) will be compared to the current gold standard (inversion recovery).
Measured: up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start13 Dec 2017
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919865
- Sponsor's protocol ID
- 20160425-01H
- Status last verified
- Oct 2021
- First submitted
- 13 Jul 2016
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of MR Perfusion Without and With Gadolinium at 3T in the Diagnosis of Patients With Suspected Recurrent High Grade Gliomas
- ClinicalTrials.gov ID
- NCT02919865
- Acronym / sponsor ID
- 20160425-01H
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 29 Sep 2016 (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.
Radiation therapy is an important adjunct in the treatment of patients with glioma, although a common side effect is radiation-induced injury of brain parenchyma. Unfortunately, conventional MRI is not accurate in differentiating radiation-induced brain injury from recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI can be performed with an injection of exogenous contrast using dynamic contrast enhancement (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be performed without contrast injection using arterial spin labeling (ASL) or intravoxel incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted contrast enhancement (DSC) perfusion is the most common technique used in clinical practice but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based techniques in differentiating recurrent tumour from radiation-induced brain injury in patients with known high grade glioma. The investigators will compare the accuracy of IVIM, ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI.
Detailed description
The aim of this study is to evaluate the diagnostic accuracy of different MR perfusion methods in differentiating recurrent tumour from radiation-induced brain injury in patients with high grade gliomas. The investigators will evaluate perfusion methods which do not use an exogenous agent (ASL, IVIM) and methods which use gadolinium as a contrast agent (DSC-MRI, DCE-MRI).
A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI. The first T1 mapping method uses a Lock-Locker inversion-recovery acquisition (MOLLI) that measures apparent T1 (T1*). The second T1 mapping method uses a single-point, saturation-recovery acquisition that measures true T1 SMART1Map.
This study is a prospective study which will involve 50 patients.
Patients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study. Informed consent by the patient or a legal guardian or authorized representative of the patient will be obtained before enrollment.
Following enrollment, MR perfusion imaging (ASL, IVIM, DSC and DCE perfusion sequences) will be performed in addition to the routine neuronavigational sequence obtained fror re-operative/ therapy planning.
Following this MR examination, the patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon. The location of the biopsy will be saved intraoperatively which will allow colocalization of histopathology with imaging data. Histopathological analysis will be performed by the neuropathologist, yielding a visual quantitative estimate of percent viable tumour and radiation necrosis within the obtained specimen.
All patients, including those who do not go to surgery, will undergo clinical followup and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who did not undergo surgery.
Following a routine clinical MR examination, patients with a new lesion or an enlarging lesion will be seen by the radiation oncologist or neurosurgeon. They will be recruited by a research nurse who will ask if they are willing to participate in the research study. If the patient agrees to participate, the investigators will add perfusion sequences in addition to the clinical MR exam for treatment planning (stereotactic radiation or reresection). The MR exam performed for clinical and research purposes will last less than 45 minutes. Following surgery, the investigators will correlate pathological findings with perfusion and diffusion parameters. If the patient does not undergo surgery, we will use clinical examination and serial MRIs (including perfusion imaging) to determine if the index lesion is more likely to represent radiation necrosis or tumor progression. The investigators will follow the patient clinically for 2 years after the time of progression to determine overall survival.
Patients with high grade gliomas are followed routinely with serial MRIs. The patients with progressive enlarging lesions will be seen by the treating oncologist or neurosurgeon.
They will electronically put in a request for another MR exam which is needed clinically for surgical planning and/or follow-up with advanced MR imaging as per standard of care.
When the patient comes to radiology for their exam, they will be asked to participate in the study by the radiologist and/or the research nurse (if this breaches patient confidentiality, we can put the radiologist as the person getting consent since he is involved in patient care). If the patient agrees to participate, the study will be performed according to the study MR protocol. If not, a standard MRI as per routine clinical practice will be performed. The investigators do not intend to recruit patients who are unable to give consent themselves since patients have to have a good Karnofsky score as an inclusion criteria in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI perfusion imaging | Other | Device: MR perfusion imagingPatients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had a diagnosis of high grade glioma and had received chemoradiation
- Developed a new lesion or an increase size of their treated lesion on follow-up MRI (either on post contrast T1W images or on FLAIR)
- Karnofsky performance status (kps) score >70 (potential candidate for reresection of stereotactic radiation)
Key exclusion criteria (8 listed)
- Patients under 18 years of age
- Pregnant patients (for women of child bearing potential - a negative serum beta HCGT is required).
- Known or suspected allergies to gadolinium-based contrast agents.
- Patients with chronic or acute renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), including acute renal insufficiency of any severity due to hepatorenal syndrome or in the perioperative liver transplantation period.
- General contraindications to MRI such as pacemaker or ferromagnetic implants.
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 |
|---|---|---|
| MR perfusion imagingMR perfusion imaging will be performed in addition to the routine neuronavigational sequence obtained from re-operative/therapy planning. Following MR examination, patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon. All patients, including those who do not go to surgery, will undergo clinical follow-up and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who do not undergo surgery. | Device | MRI perfusion imaging |
Primary outcome
Estimate the Receiver Operating Characteristic (ROC) curve
Time frame: up to 22 months
Estimate the Receiver Operating Characteristic (ROC) curve for the assessment of the diagnostic accuracy of f, CBF, CBV, Cp and Ktrans, obtained from different MR perfusion acquisition methods for distinguishing recurrent tumour from radiation necrosis.
1 secondary outcome
Different T1 mapping methods used for DCE-MRI will be compared to the current gold standard
Time frame: up to 22 months
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 8 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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 MR perfusion imaging in people with Glioma, run by Ottawa Hospital Research Institute 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 8 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 8 Oct 2021. 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?
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?
Estimate the Receiver Operating Characteristic (ROC) curve (time frame: up to 22 months). 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 8 Oct 2021.