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Clinical Trials in Italy / NCT07431255
Starting soon Observational

Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease

NCT07431255 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2026-03-01
Last updated
2026-02-24

Condition(s) studied

Alzheimer Disease (AD)

Study summary

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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Quantitative Accuracy of Synthetic FDG PET Images (SUVR Correlation and MAE) — Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025
    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).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele Milan Lombardy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07431255 on ClinicalTrials.gov ↗ ← All trials in Italy