Radialis PET Imager for Alzheimer's Disease

(Amyloid RPI Trial)

Overseen By Ur Metser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain imaging device, the Radialis PET Imager, to determine if it performs as well as standard PET scans in detecting Alzheimer's disease. The goal is to assess whether this device can meet the growing demand for brain scans in Alzheimer's patients by providing a comparable and more accessible option. Participants should have cognitive issues and be able to remain still for about 30-45 minutes during the scan. This observational study compares images from the new device with those from standard machines. As an unphased trial, it offers participants the chance to contribute to advancements in Alzheimer's diagnostics by testing innovative imaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Radialis PET Imager is safe for use in brain imaging?

Research has shown that the Radialis PET Imager received FDA approval for use with certain tracers, confirming it meets safety standards for those applications. Other studies have found it produces images comparable to standard PET devices when used with different tracers. This suggests the device is safe and poses no greater risks than regular imaging equipment. However, this trial specifically tests its effectiveness with an amyloid tracer for Alzheimer’s, which remains untested. Although specific safety data for this use is unavailable, previous approval and studies suggest it is likely safe. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Radialis PET Imager for Alzheimer's disease because it offers a new way to visualize brain activity with high precision. Unlike traditional imaging methods, like MRI or CT scans, the Radialis PET Imager provides detailed insights into the metabolic processes in the brain, which can help identify the presence and progression of Alzheimer's more accurately. This advanced imaging technique could lead to earlier and more reliable diagnoses, allowing for timely interventions and better management of the disease.

What evidence suggests that the Radialis PET Imager is effective for Alzheimer's Disease imaging?

Studies have shown that standard PET scans using special markers effectively reveal brain changes related to Alzheimer's disease. The Radialis PET Imager (RPI), which participants in this trial will use, is a new type of PET scanner that matched the performance of standard PET machines in past tests with different markers. This suggests it might also work well for detecting Alzheimer's. RPI is portable and more affordable, making it a practical choice compared to standard PET machines. Although RPI hasn't been specifically tested for Alzheimer's markers yet, its previous success with other markers is encouraging. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with cognitive impairment or Alzheimer's disease who need amyloid PET imaging. Participants must be eligible for standard brain amyloid PET scans as part of their usual care. The Radialis PET imager hasn't been approved by Health Canada but can be used in this study.

Inclusion Criteria

I can stay still for an extra 30-45 minutes for a scan.

Patients with cognitive impairment undergoing the standard of care brain 18F-Florbetaben PET imaging

Exclusion Criteria

I am unable to understand or sign the consent form.

I cannot have a PET scan due to pregnancy or difficulty staying still.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Optimization

Optimization of brain PET imaging technique and data reconstruction methods using RPI. Up to 10 patients will be recruited and scanned on the RPI camera after their clinical PET scan.

3 months

1 visit (in-person) per patient

Phase II - Validation

Validation of RPI against standard PET for amyloid PET imaging. 150 patients will be assessed using the finalized imaging protocol.

18 months

1 visit (in-person) per patient

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Radialis PET Imager

Trial Overview The trial is testing the Radialis PET Imager (RPI), a new, mobile and potentially more affordable alternative to standard PET/CT or PET/MR scanners, to see if it provides comparable brain images when using an amyloid tracer.

How Is the Trial Designed?

Group I: Single arm, observational Experimental Treatment 1 Intervention

Single arm, observational

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

A novel multimodal imaging marker, developed using a deep learning algorithm, can predict which patients with mild cognitive impairment (MCI) are most likely to decline to dementia, enhancing the efficiency of clinical trials.

Using this imaging marker as an inclusion criterion can reduce the required sample size for trials by at least five times, allowing for smaller, more statistically powerful studies compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging-based enrichment criteria using deep learning algorithms for efficient clinical trials in mild cognitive impairment. Ithapu, VK., Singh, V., Okonkwo, OC., et al.[2018]

High-resolution SPECT imaging can help diagnose Alzheimer's disease (AD) by identifying specific patterns of reduced blood flow in the brain, particularly in the frontal and temporoparietal areas, which are often affected early in the disease.

In patients with mild cognitive symptoms, SPECT can enhance diagnostic accuracy by revealing focal hypoperfusion, while in those with probable AD, it can confirm the diagnosis when combined with findings of brain atrophy from CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional brain imaging with single-photon emission computed tomography in the diagnosis of Alzheimer's disease. Waldemar, G., Høgh, P., Paulson, OB.[2019]

The study developed a standardized voxel of interest (VOI) template that significantly improves the ability to distinguish between Alzheimer's disease (AD) patients and healthy controls using the PET radioligand 11C-PIB, achieving complete separation in a test cohort of 9 AD and 4 control subjects.

This VOI template, which can potentially replace manual delineation methods, offers a more efficient and automated approach for assessing amyloid-beta accumulation in clinical settings, enhancing diagnostic capabilities for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voxel-based analysis of 11C-PIB scans for diagnosing Alzheimer's disease. Mikhno, A., Devanand, D., Pelton, G., et al.[2021]

SPECT scanning can effectively differentiate between early Alzheimer's disease (AD) and healthy elderly individuals by measuring regional cerebral blood flow (rCBF), particularly in the prefrontal and parietal cortices.

In a study of 28 subjects (18 with early AD and 10 healthy controls), significant reductions in rCBF were observed in specific brain regions of AD patients, suggesting that SPECT could be a valuable diagnostic tool when standardized techniques are applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional cerebral blood flow deficits in mild Alzheimer's disease using high resolution single photon emission computerized tomography. Trollor, JN., Sachdev, PS., Haindl, W., et al.[2016]

The ROVER software provides a new way to analyze brain (18)F-FDG-PET images, showing that it can accurately measure brain glucose uptake and distinguish between Alzheimer's disease (AD) patients and healthy controls in a pilot study of 14 AD patients and 18 controls.

ROVER-derived brain volumes were significantly lower in AD patients compared to controls, with diagnostic accuracy comparable to traditional voxel-based analyses, indicating its potential as a valuable tool for assessing brain metabolism in AD and other neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of estimation of brain volume and 2-deoxy-2-(18)F-fluoro-D-glucose metabolism using a novel automated image analysis method: application in Alzheimer's disease. Musiek, ES., Saboury, B., Mishra, S., et al.[2016]

In a study of 167 patients with mild cognitive problems, PET scans measuring brain metabolism were able to predict cognitive decline, showing that 94% of patients with positive scans progressed in their condition compared to only 25% with negative scans.

The results suggest that using PET scans can significantly enhance the accuracy of predicting the clinical course of cognitive decline, with a relative risk of 3.8 for those predicted to decline and 18.4 for those expected to remain stable but who had positive scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of regional cerebral metabolism in patients undergoing dementia evaluation: comparison to a quantifying parameter of subsequent cognitive performance and to prognostic assessment without PET. Silverman, DH., Truong, CT., Kim, SK., et al.[2016]

The automated cortical surface mapping (CSM) method for analyzing PET scans significantly improves the efficiency of extracting regional data, making it easier to classify Alzheimer's disease patients compared to those with mild cognitive impairment and healthy controls.

Using a single set of VOIs generated through this automated process resulted in better classification accuracy than traditional manual methods, indicating that it can reduce measurement variance and enhance the reliability of PET data analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated VOI Analysis in FDDNP PET Using Structural Warping: Validation through Classification of Alzheimer's Disease Patients. Wilks, MQ., Protas, H., Wardak, M., et al.[2021]

MRI and PET brain imaging have greatly enhanced the understanding and diagnosis of various dementia syndromes over the past 20 years, helping to identify specific patterns and effects on brain function.

These imaging techniques are now commonly used in clinical trials to determine eligibility and measure treatment outcomes, highlighting their importance in advancing dementia research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain imaging in dementia. Bonifacio, G., Zamboni, G.[2017]

A new semiautomated method for defining regions of interest (ROIs) in SPECT imaging was tested on 10 patients with probable Alzheimer's disease and 7 healthy subjects, showing promise for more accurate diagnosis of senile dementia.

The study found that specific ratios of brain activity (parietal to cerebellar and parietal to mean cortical activity) could effectively differentiate between patients with Alzheimer's and healthy controls, correlating with the severity of cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer disease: quantitative analysis of I-123-iodoamphetamine SPECT brain imaging. Hellman, RS., Tikofsky, RS., Collier, BD., et al.[2016]

New diagnostic criteria for Alzheimer's disease (AD) focus on biomarkers related to synaptic dysfunction and neurodegeneration, enhancing clinical detection methods.

Advanced imaging techniques like MRI and PET scans can effectively identify key indicators of AD, such as medial-temporal atrophy and amyloid protein retention, aiding in diagnosis and monitoring treatment progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brain imaging of Alzheimer' disease: state of the art and perspectives for clinicians]. Trombella, S., Assal, F., Zekry, D., et al.[2016]

Citations

1. trialx.com trialx.com/clinical-trials/listings/293908/radialis-pet-imager-for-the-assessment-of-neuritic-amyloid-plaque-burden/

Radialis PET Imager for the Assessment of Neuritic ... This imaging can visualize your brain. With the development of new therapies for Alzheimer's disease which require amyloid PET imaging ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8134674/

PET Neuroimaging of Alzheimer's Disease: Radiotracers and ... In this article we survey the various PET radiotracers available for AD imaging and discuss their clinical applications especially in terms of early detection ...

3. bmcneurosci.biomedcentral.com bmcneurosci.biomedcentral.com/articles/10.1186/s12868-025-00978-0

Comparative study of 18 F-labeled PET radiopharmaceuticals ... Conclusions. 18F-FBB emerged as the most effective radiopharmaceutical for imaging amyloid deposition in AD mouse models, providing superior ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024104331

Alzheimer's disease stage recognition from MRI and PET ... We found that the fused image was consistent in all metrics, having 0.64 SIMM, 35.60 PSNR, and 0.21 MSE for the FDG-PET image. In the ...

5. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-025-01276-w

Head to head comparison of two PET/CT imaging agents, [18F ... A head-to-head comparison between these two imaging agents was conducted in AD patients. A separate biodistribution study was conducted on six ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06757569

Radialis PET Imager for the Assessment of Neuritic ... The standard or usual workup for cognitive impairment, including Alzheimer's Disease, may include brain amyloid PET with PET/CT or PET/MR ...

7. studies.bethecure.ca studies.bethecure.ca/find/487426cb1ec3300027d3da514ceb91b6f285fb24-radialis-pet-imager-for-the-assessment-of-neuri

Radialis PET Imager for the Assessment of Neuritic Amyloid ... 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 ...

8. auntminnie.com auntminnie.com/clinical-news/molecular-imaging/article/15631461/fda-clears-radialis-pet-imager

FDA clears Radialis PET imager The U.S. Food and Drug Administration (FDA) has cleared Radialis' PET Imager, a small footprint, organ-targeted device.

9. radialis.com radialis.com/

RADIALIS The Radialis PET Imager is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10999605/

Image quality evaluation for a clinical organ-targeted PET ... Demonstrated ability to accurately reconstruct activity in tumors as small as 5 mm suggests that the Radialis PET technology may be well suited for emerging ...