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

NCT07431255 | Not Yet Recruiting

• 1 other identifier: ALZ-AI
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease (AD)

Keywords

Alzheimer Disease; Amyloid PET; FDG PET; Artificial Intelligence; Deep Learning; Retrospective Study; Neuroimaging; Positron Emission Tomography; Florbetaben; Flutemetamol; Image Processing; Diagnostic Imaging

Outcome Measures

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).

  Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025

Secondary Outcomes (1)

• Regional SUVR Bias Between Synthetic and Native FDG Across Machine Types

  Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025

Other Outcomes (1)

• Effect of Amyloid Status on Synthetic FDG Generation Accuracy

  Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025

Study Arms (1)

Patients with cognitive impairment undergoing amyloid PET

Adults (≥50 years) with cognitive symptoms who underwent amyloid PET (Florbetaben or Flutemetamol), structural MRI, and \[18F\]FDG PET at IRCCS Ospedale San Raffaele between January 2025 and December 2025 as part of routine diagnostic care. All data are fully anonymized prior to analysis.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Clinical Trial Center Nuclear Medicine Unit

CONTACT

+39-02-2643-2716; mednuc@hsr.it

CTC First Contact ctc.firstcontact@hsr.it

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arturo Chiti

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

IT (1)