Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden
Recruiting
N/AInterventional Study
Cognitive Impairment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
160 (estimated)
Sponsor
University Health Network, Toronto · Other
Who this trial is looking for
This trial is looking for adults with cognitive impairment who are scheduled for a standard brain scan. Participants will receive a special PET scan that is being tested for its effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have cognitive impairment
I can stay still for about 30-45 minutes for a scan
You may not be able to join if
I cannot provide informed consent
I cannot have a PET scan due to safety guidelines, such as being pregnant
I cannot stay still for the PET examination
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The standard or usual workup for cognitive impairment, including Alzheimer's Disease, may include brain amyloid PET with PET/CT or PET/MR imaging. Amyloid PET is the standard imaging that was requested for you by your referring physician. This imaging can visualize your brain.
With the development of new therapies for Alzheimer's disease which require amyloid PET imaging, there will be a signific…
The standard or usual workup for cognitive impairment, including Alzheimer's Disease, may include brain amyloid PET with PET/CT or PET/MR imaging. Amyloid PET is the standard imaging that was requested for you by your referring physician. This imaging can visualize your brain.
With the development of new therapies for Alzheimer's disease which require amyloid PET imaging, there will be a significant increase in the number of PET scans needed to provide care to all patients. There are likely not enough PET scanners in Canada to meet this demand. Therefore, we are searching for comparable alternatives. One of the imaging devices that was introduced in the clinic is the Radialis PET imager (or RPI). Health Canada, the regulatory body that oversees the use of devices in Canada, has not approved the sale or use of the Radialis PET imager. Health Canada has allowed the Radialis PET imager to be used in this study. We would like to see whether the images obtained for the brain are comparable to those obtained from a PET/CT or PET/MRI scanner. It is a new type of PET imaging device for patients undergoing a PET scan and has been used in Canada for research. RPI is experimental, meaning that this PET scan is not used routinely in patients' care.
In comparison to the standard PET devices, RPI is smaller and mobile, meaning it can be moved around easily for use. Also, it can be installed in imaging centers at a lower cost. These advantages make RPI an interesting alternative to the standard PET. However, the performance of this new imaging device has not been tested in Amyloid PET imaging in particular.
As you may know, in a PET scan, we inject a radioactive material (called tracer) which can circulate in your body and visualize specific areas in your body. In amyloid PET we inject an amyloid tracer that goes to the brain and lights up certain regions of the brain.
RPI was previously tested for other PET tracers and was shown to be comparable to standard PET devices. Thus, by changing the PET material (to Amyloid), we are pursuing the same aim: comparison of RPI with standard PET devices and see whether it can provide comparable images of the brain.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years
2. Patients with cognitive impairment undergoing the standard of care brain 18F-Florbetaben PET imaging.
3. Patients who can remain still for an additional scan of approximately 30-45 minutes.
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Exclusion Criteria:
1\. Inability to provide informed con…
Inclusion Criteria:
1. Age ≥18 years
2. Patients with cognitive impairment undergoing the standard of care brain 18F-Florbetaben PET imaging.
3. Patients who can remain still for an additional scan of approximately 30-45 minutes.
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Exclusion Criteria:
1\. Inability to provide informed consent. 2. Contraindication for PET examination as per institutional safety guidelines, including but not limited to pregnancy or inability to remain still for PET examination.
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