NCT06757569 Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden
| NCT ID | NCT06757569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-12-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. \- 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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06757569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06757569 currently recruiting?
Yes, NCT06757569 is actively recruiting participants. Contact the research team at ur.metser@uhn.ca for enrollment information.
Where is the NCT06757569 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06757569 clinical trial?
NCT06757569 is sponsored by University Health Network, Toronto. The trial plans to enroll 160 participants.