Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden
New PET Scanner Tested for Alzheimer's Diagnosis
Plain English Summary
Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden is a Not Applicable clinical trial sponsored by University Health Network, Toronto studying Cognitive Impairment. This study tests a new, mobile PET scanner called Radialis PET Imager (RPI) to see if it can create clear images of amyloid plaques in the brain, similar to current PET scanners. It is for adults experiencing cognitive impairment who are already scheduled for a standard brain PET scan to check for amyloid plaques, a hallmark of Alzheimer's disease. Participants will undergo their usual PET scan and then an additional scan with the new RPI device, which takes about 30-45 minutes longer. The alternative is the standard PET/CT or PET/MRI scan, which are currently the approved methods for this type of imaging. The trial aims to enroll 160 participants.
Official 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,
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who have cognitive impairment and are undergoing a standard PET scan for amyloid plaques can join. Individuals who cannot remain still during the scan or have reasons why they cannot have a PET scan (like pregnancy) cannot participate. You must be able to give your informed consent to join the study. This trial is studying Cognitive Impairment, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary goal is to determine if the new Radialis PET Imager can successfully produce clear images of amyloid plaques in the brain, meaning it can be a reliable tool for diagnosing conditions like The specific primary outcome measures are: feasibility of amyloid brain PET imaging using RPI (2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because new Alzheimer's treatments require more PET scans, and this study explores a potentially more accessible and cost-effective imaging alternative to meet the growing dema This research targets Cognitive Impairment, where improved treatment options are needed.
Investor Insight
This trial signals a potential innovation in diagnostic imaging for Alzheimer's, addressing a growing need for PET scans and exploring a new device that could be more widely available and cheaper to i
Is This Trial Right for Me?
Ask your doctor if this new scanner is right for you and what the extra scan involves. Participation means you'll have your standard PET scan plus an additional 30-45 minute scan with the new device. You'll need to lie still for the duration of both scans. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 160 participants
Interventions
- DEVICE: PET — Feasibility assessment of using the Radialis PET Imager for the detection of amyloid plaque burden using PET amyloid tracer.
Primary Outcomes
- feasibility of amyloid brain PET imaging using RPI (2 years)
Secondary Outcomes
- Qualitative assessment (2 years)
- Tracer Dose (2 years)
- Acquisition Time (2 years)
Full 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. \-
Trial Locations
- University Health Network, Toronto, Toronto, Ontario, Canada
Frequently Asked Questions
What is clinical trial NCT06757569?
NCT06757569 is a Not Applicable INTERVENTIONAL study titled "Radialis PET Imager for the Assessment of Neuritic Amyloid Plaque Burden." It is currently recruiting and is sponsored by University Health Network, Toronto. The trial targets enrollment of 160 participants.
What conditions does NCT06757569 study?
This trial investigates treatments for Cognitive Impairment. The primary condition under study is Cognitive Impairment.
What treatments are being tested in NCT06757569?
The interventions being studied include: PET (DEVICE). Feasibility assessment of using the Radialis PET Imager for the detection of amyloid plaque burden using PET amyloid tracer.
What does Not Applicable mean for NCT06757569?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06757569?
This trial is currently "Recruiting." It started on 2024-12-06. The estimated completion date is 2026-12-31.
Who is sponsoring NCT06757569?
NCT06757569 is sponsored by University Health Network, Toronto. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06757569?
The trial aims to enroll 160 participants. The trial is currently recruiting and accepting new participants.
How is NCT06757569 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06757569?
The primary outcome measures are: feasibility of amyloid brain PET imaging using RPI (2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06757569 being conducted?
This trial is being conducted at 1 site, including Toronto, Ontario (Canada).
Where can I find official information about NCT06757569?
The official record for NCT06757569 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06757569. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06757569 testing in simple terms?
This study tests a new, mobile PET scanner called Radialis PET Imager (RPI) to see if it can create clear images of amyloid plaques in the brain, similar to current PET scanners. It is for adults experiencing cognitive impairment who are already scheduled for a standard brain PET scan to check for amyloid plaques, a hallmark of Alzheimer's disease.
Why is this trial significant?
This trial is important because new Alzheimer's treatments require more PET scans, and this study explores a potentially more accessible and cost-effective imaging alternative to meet the growing dema
What are the potential risks of participating in NCT06757569?
The main risk is the small additional radiation exposure from the second scan, though it's expected to be within safe limits. As with any PET scan, there's a small risk of an allergic reaction to the tracer, though this is rare. The new scanner is experimental, so its long-term effects are not yet fully known. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06757569?
Ask your doctor if this new scanner is right for you and what the extra scan involves. Participation means you'll have your standard PET scan plus an additional 30-45 minute scan with the new device. You'll need to lie still for the duration of both scans. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06757569 signal from an investment perspective?
This trial signals a potential innovation in diagnostic imaging for Alzheimer's, addressing a growing need for PET scans and exploring a new device that could be more widely available and cheaper to i This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo their usual PET scan and then an additional scan with the new RPI device, which takes about 30-45 minutes longer. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.