Alzheimer Disease (AD)NCT07431255
Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease
An observational study of Alzheimer Disease (AD), run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease (AD)
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
CTC First Contact ctc.firstcontact@hsr.it contact
About this study
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.
Read the detailed description
This is a retrospective observational study conducted at IRCCS Ospedale San Raffaele, Milan, Italy. The study evaluates the accuracy of synthetic [18F]FDG PET images generated using a SwinUNETR deep learning model compared to native [18F]FDG PET images.
Study Population:
Adults (≥ 50 years) who underwent amyloid PET imaging (using Florbetaben or Flutemetamol), structural MRI, and [18F]FDG PET due to cognitive symptoms between January 2025 and December 2025. Approximately 35 patients meeting inclusion criteria will be included.
Methodology:
All imaging and clinical data were collected as part of routine diagnostic care; thus, no additional procedures, interventions, or interactions with patients are required for this study. All data are fully deidentified before analysis, consistent with GDPR and institutional data protection policy. The SwinUNETR model processes volumetric images to generate synthetic FDG PET images from early-phase amyloid PET and MRI inputs.
Objectives and Endpoints:
Primary Objective: To quantitatively and qualitatively assess the accuracy of synthetic FDG PET images compared with native FDG PET images.
Primary Endpoint: 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).
Secondary Objective: To assess visual interpretability and clinical intuitiveness of synthetic FDG PET images by expert nuclear medicine physicians.
Secondary Endpoint: Inter-rater agreement (Cohen's kappa) among 2 blinded nuclear medicine physicians rating synthetic FDG scans as "clinically acceptable" or not.
Ethical Considerations:
Due to the retrospective and non-interventional nature of this study, no additional informed consent is required. A waiver of informed consent will be requested from the Ethics Committee. The image data will be fully anonymized in accordance with institutional policies.
- 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
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Regional SUVR bias (mean difference ± standard deviation) between synthetic and native FDG across machine types and reconstructions used at Ospedale San Raffaele.
Measured: Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431255
- Sponsor's protocol ID
- ALZ-AI
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided whether individual participant data will be shared. The research team will consider data sharing requests on a case-by-case basis, subject to institutional approval and data use agreements. Anonymized imaging data (NIfTI format) and analysis scripts may be made available upon reasonable request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07431255
- Acronym / sponsor ID
- ALZ-AI
- Conditions
- Alzheimer Disease (AD)
- Keywords
- Alzheimer Disease, Amyloid PET, FDG PET, Artificial Intelligence, Deep Learning, Retrospective Study, Neuroimaging, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective observational study conducted at IRCCS Ospedale San Raffaele, Milan, Italy. The study evaluates the accuracy of synthetic [18F]FDG PET images generated using a SwinUNETR deep learning model compared to native [18F]FDG PET images.
Study Population:
Adults (≥ 50 years) who underwent amyloid PET imaging (using Florbetaben or Flutemetamol), structural MRI, and [18F]FDG PET due to cognitive symptoms between January 2025 and December 2025. Approximately 35 patients meeting inclusion criteria will be included.
Methodology:
All imaging and clinical data were collected as part of routine diagnostic care; thus, no additional procedures, interventions, or interactions with patients are required for this study. All data are fully deidentified before analysis, consistent with GDPR and institutional data protection policy. The SwinUNETR model processes volumetric images to generate synthetic FDG PET images from early-phase amyloid PET and MRI inputs.
Objectives and Endpoints:
Primary Objective: To quantitatively and qualitatively assess the accuracy of synthetic FDG PET images compared with native FDG PET images.
Primary Endpoint: 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).
Secondary Objective: To assess visual interpretability and clinical intuitiveness of synthetic FDG PET images by expert nuclear medicine physicians.
Secondary Endpoint: Inter-rater agreement (Cohen's kappa) among 2 blinded nuclear medicine physicians rating synthetic FDG scans as "clinically acceptable" or not.
Ethical Considerations:
Due to the retrospective and non-interventional nature of this study, no additional informed consent is required. A waiver of informed consent will be requested from the Ethics Committee. The image data will be fully anonymized in accordance with institutional policies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Accuracy of Synthetic FDG PET Images (SUVR Correlation and MAE)
Time frame: 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).
1 secondary outcome
Regional SUVR Bias Between Synthetic and Native FDG Across Machine Types
Time frame: Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided. It is not yet decided whether individual participant data will be shared. The research team will consider data sharing requests on a case-by-case basis, subject to institutional approval and data use agreements. Anonymized imaging data (NIfTI format) and analysis scripts may be made available upon reasonable request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CTC First Contact ctc.firstcontact@hsr.it contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease (AD), run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Center Nuclear Medicine Unit (+39-02-2643-2716, mednuc@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Accuracy of Synthetic FDG PET Images (SUVR Correlation and MAE) (time frame: Retrospective analysis of imaging data acquired between January 1, 2025 and December 31, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.