Recruiting

Radialis PET Imager

Sponsor:

University Health Network, Toronto

Code:

NCT06757569

Conditions

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET

Study Details

Brief 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.

Conditions

Cognitive Impairment

Study ID

NCT06757569

Start date

Dec 6, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Single arm, observational

Single arm, observational

Interventions

PET

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

Primary outcome measure

  • feasibility of amyloid brain PET imaging using RPI [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

University Health Network, Toronto

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • Amyloid, PET, Alzheimer's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-02-03.