RecruitingNot ApplicableNCT06757569

Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden


Sponsor

University Health Network, Toronto

Enrollment

160 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new, smaller PET imaging device called the Radialis PET Imager to see if it can accurately detect the buildup of amyloid plaques in the brain — a hallmark of Alzheimer's disease — in people who are already scheduled for a standard brain amyloid PET scan. **You may be eligible if...** - You are 18 or older - You have cognitive impairment (memory or thinking problems) and are already scheduled to have a standard brain amyloid PET scan as part of your care - You are able to remain still for an additional 30–45 minutes during the scan **You may NOT be eligible if...** - You are unable to give informed consent - You are pregnant - You are unable to remain still for a PET scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPET

Feasibility assessment of using the Radialis PET Imager for the detection of amyloid plaque burden using PET amyloid tracer.


Locations(1)

University Health Network, Toronto

Toronto, Ontario, Canada

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NCT06757569


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