Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease
ConditionAlzheimer Disease (AD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorIRCCS San Raffaele
About this trial
This study aims to test a new artificial intelligence (AI) method to create brain scan images without needing an extra scan. Currently, patients with memory problems often undergo two types of PET scans (Amyloid PET and FDG PET) to assess Alzheimer's disease. This study will use existing scan data from patients who already had both scans as part of their routine care.
The AI model will try to generate the FDG PET image using only the Amyloid PET scan and an MRI. If successful, this method could reduce radiation exposure, costs, and time for future patients by eliminating the need for a separate FDG injection and scan.
No new scans, injections, or procedures will be performed for this study. All data will be fully anonymized (personal information removed) before analysis. The study involves approximately 35 adult patients (age 50+) whose data were collected between January 2025 and December 2025 at IRCCS Ospedale San Raffaele in Milan, Italy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 50 years at the time of imaging.
Clinically indicated amyloid PET scan performed with Florbetaben or Flutemetamol between January 1, 2025 and December 31, 2025.
Availability of paired structural MRI (3D T1-weighted) and real [18F]FDG PET scan acquired within ±6 months of the amyloid PET.
All three imaging modalities (Amyloid PET, FDG PET, MRI) are of sufficient technical quality for co-registration and quantitative analysis.
Disqualifiers
Presence of other major neurological disorders that may confound FDG metabolism (e.g., Parkinson's disease, frontotemporal dementia, brain tumor, or recent stroke).
Severe motion artifacts or technical failures in any of the three imaging modalities that prevent reliable co-registration or SUVR calculation.
Incomplete or irreversibly corrupted DICOM data preventing anonymization or conversion to analysis-ready format.
Trial population
Adults (≥50 years) with cognitive symptoms who underwent amyloid PET imaging (Florbetaben or Flutemetamol), structural MRI, and \[18F\]FDG PET at the Nuclear Medicine Department of IRCCS Ospedale San Raffaele, Milan, Italy, as part of routine diagnostic care between January 1, 2025 and December 31, 2025.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
35 Participants
are grouped into 1 trial groupGroup A: Patients with cognitive impairment undergoing amyloid PET
Trial outcomes
Primary outcomes
1
Quantitative Accuracy of Synthetic FDG PET Images (SUVR Correlation and MAE)
Pearson correlation coefficient and mean absolute error (MAE) of SUVR values obtained from native FDG PET and synthetic FDG PET in Alzheimer relevant areas of interest (precuneus, posterior cingulate, lateral temporal cortex, and frontal cortex).
Time frame
Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025Secondary outcomes
1
Regional SUVR Bias Between Synthetic and Native FDG Across Machine Types
Regional SUVR bias (mean difference ± standard deviation) between synthetic and native FDG across machine types and reconstructions used at Ospedale San Raffaele.
Time frame
Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025Other outcomes
1
Effect of Amyloid Status on Synthetic FDG Generation Accuracy
Stratified analysis of primary endpoint (SUVR correlation and MAE) by state of amyloid PET positivity (positive vs negative) based on established Centiloid or visual read criteria.
Time frame
Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: