Malignant GliomaDTPI FDG-PETNCT02391246
Radionecrosis and FDG PET
An observational study of Malignant Glioma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Gliomas are the most common malignant primary central nervous system (CNS) tumours. When high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional sequences is required.The Positron Emission Tomography (PET) radiotracer [18F]-fluorodeoxyglucose (FDG) will be used in this study to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Positron Emission Tomography Imaging
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be patients who have previously been treated with radiochemotherapy for high grade gliomas who are clinically assessed with a brain MRI for suspected disease recurrence.
Who may be able to join
- Age ≥ 18 years old
- Able and willing to comply with the study procedures
- The patient must be followed at The Ottawa Hospital for a tissue-proven, grade III or IV glioma.
- The patient must have been treated in the past with radiotherapy for glioma.
- A disease recurrence is suspected based on clinical symptoms and/or imaging results.
Who cannot join
- Missing information regarding tumor type and grade
- Brain biopsy in the ten days preceding DTPI FDG-PET
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Ioana D Moldovan, MD Msc, 613-798-5555 ext. 18574, imoldovan@ohri.ca
Lionel S Zuckier, MD
About this study
Official title: A Dual Time Point FDG-PET to Differentiate Between Recurrent Brain Tumor and Radionecrosis
Gliomas are the most common malignant primary central nervous system (CNS) tumours. When high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional sequences is required.The Positron Emission Tomography (PET) radiotracer [18F]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.
Read the detailed description
Molecular imaging has been used to distinguish recurrent tumor from post-treatment changes through the use of positron emission tomography (PET) as well as other techniques. The best-studied PET radiotracer for this application is [18F]-fluorodeoxyglucose (FDG). Normal brain matter is very FDG-avid, making it more difficult to identify lesions and in addition, inflammation associated with radiation injury has been shown to be FDG avid.
In light of this, variations of the standard FDG protocols have been proposed in order to increase overall accuracy, including dual time point imaging (DTPI), consisting of injecting the patient with the standard radiotracer and acquiring two sets of images several hours apart, typically the normal initial images in addition to a delayed acquisition set.
There is good reason to suspect that DTPI FDG-PET would be useful a technique for characterizing lesions in the brain. It's been shown that FDG uptake by normal brain parenchyma initially increases then decreases with time, while tumor uptake typically increases and then plateaus. This pattern of increasing and then decreasing FDG activity has also been seen in inflammatory tissue. The difference in FDG uptake at different times is what allows for a better distinction between malignant and benign tissue.
- Conditions
- Malignant Glioma
- Being tested
- Positron Emission Tomography Imaging
- Keywords
- central nervous system tumours, [18F]-fluorodeoxyglucose
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography ImagingOther
Participants will receive an intravenous injection of 250 MBq (megabecquerels) of 18F-Fluorodeoxyglucose (18F-FDG). The first Positron Emission Tomography (PET) acquisition of the head will occur one hour post-injection. The second acquisition will take place 3 hours post-injection. Both early and late PET images will be manually co-registered with the participant's most recent magnetic resonance images.
| Study group | Role | What they receive |
|---|---|---|
| Positron Emission Tomography Imaging | Dual time point imaging with 250 MBq of 18F-Fluorodeoxyglucose (18F-FDG) Receives: Other: Positron Emission Tomography Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity percentages
The sensitivity and specificity of dual time point imaging (DTPI) FDG-PET/CT will be compared to the sensitivity and specificity of MR imaging obtained as standard of care for identifying glioma recurrence post-treatment.
Measured: 3 years
Secondary outcomes (1)
Cost efficiency analysis
At the conclusion of the trial, a cost-efficiency analysis will be performed in an attempt to determine an optimally accurate and cost-efficient imaging strategy for the diagnosis of glioma recurrence.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lionel Zuckier, Ottawa Hospital Research Institute
- Investigators
- Lionel S Zuckier, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391246
- Sponsor's protocol ID
- 20150094-01H
- Acronym
- DTPI FDG-PET
- Status last verified
- Aug 2019
- First submitted
- 8 Feb 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dual Time Point FDG-PET to Differentiate Between Recurrent Brain Tumor and Radionecrosis
- ClinicalTrials.gov ID
- NCT02391246
- Acronym / sponsor ID
- DTPI FDG-PET / 20150094-01H
- Conditions
- Malignant Glioma
- Keywords
- central nervous system tumours, [18F]-fluorodeoxyglucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 18 Mar 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.
Gliomas are the most common malignant primary central nervous system (CNS) tumours. When high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional sequences is required.The Positron Emission Tomography (PET) radiotracer [18F]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.
Detailed description
Molecular imaging has been used to distinguish recurrent tumor from post-treatment changes through the use of positron emission tomography (PET) as well as other techniques. The best-studied PET radiotracer for this application is [18F]-fluorodeoxyglucose (FDG). Normal brain matter is very FDG-avid, making it more difficult to identify lesions and in addition, inflammation associated with radiation injury has been shown to be FDG avid.
In light of this, variations of the standard FDG protocols have been proposed in order to increase overall accuracy, including dual time point imaging (DTPI), consisting of injecting the patient with the standard radiotracer and acquiring two sets of images several hours apart, typically the normal initial images in addition to a delayed acquisition set.
There is good reason to suspect that DTPI FDG-PET would be useful a technique for characterizing lesions in the brain. It's been shown that FDG uptake by normal brain parenchyma initially increases then decreases with time, while tumor uptake typically increases and then plateaus. This pattern of increasing and then decreasing FDG activity has also been seen in inflammatory tissue. The difference in FDG uptake at different times is what allows for a better distinction between malignant and benign tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positron Emission Tomography Imaging | – | Other: Positron Emission Tomography ImagingDual time point imaging with 250 MBq of 18F-Fluorodeoxyglucose (18F-FDG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients who have previously been treated with radiochemotherapy for high grade gliomas who are clinically assessed with a brain MRI for suspected disease recurrence.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Able and willing to comply with the study procedures
- The patient must be followed at The Ottawa Hospital for a tissue-proven, grade III or IV glioma.
- The patient must have been treated in the past with radiotherapy for glioma.
- A disease recurrence is suspected based on clinical symptoms and/or imaging results.
Key exclusion criteria (5 listed)
- Missing information regarding tumor type and grade
- Brain biopsy in the ten days preceding DTPI FDG-PET
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
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 |
|---|---|---|
| Positron Emission Tomography ImagingParticipants will receive an intravenous injection of 250 MBq (megabecquerels) of 18F-Fluorodeoxyglucose (18F-FDG). The first Positron Emission Tomography (PET) acquisition of the head will occur one hour post-injection. The second acquisition will take place 3 hours post-injection. Both early and late PET images will be manually co-registered with the participant's most recent magnetic resonance images. | Other | Positron Emission Tomography Imaging |
Primary outcome
sensitivity and specificity percentages
Time frame: 3 years
The sensitivity and specificity of dual time point imaging (DTPI) FDG-PET/CT will be compared to the sensitivity and specificity of MR imaging obtained as standard of care for identifying glioma recurrence post-treatment.
1 secondary outcome
Cost efficiency analysis
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Lionel S Zuckier, MD principal investigator
The Ottawa Hospital
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 Malignant 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 5 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlie Poirier, BScN (613-761-5103, mpoirier@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity percentages (time frame: 3 years). 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 28 Aug 2019.