Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden

NCT06757569 | Recruiting

• 1 other identifier: 24-5482
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

Amyloid, PET, Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• feasibility of amyloid brain PET imaging using RPI

  Number of diagnostic exams performed with RPI compared to standard PET.

  2 years

Secondary Outcomes (3)

• Qualitative assessment

  2 years

• Tracer Dose

  2 years

• Acquisition Time

  2 years

Study Arms (1)

Single arm, observational

OTHER

Single arm, observational

Device: PET

Interventions

PET DEVICE

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

Single arm, observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients with cognitive impairment undergoing the standard of care brain 18F-Florbetaben PET imaging.
• Patients who can remain still for an additional scan of approximately 30-45 minutes.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Ur Metser

CONTACT

416-946-4501; ur.metser@uhn.ca

Noosha Yazdani

CONTACT

416-946-4501; noosha.yazdani@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ur Metser

Model Details: Single arm cohort study

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 3, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CA (1)