NCT07417540Completed
Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease
A Single-Center, Retrospective, Rater-Blinded, Crossover Study to Evaluate the Efficacy of the Medical Image Analysis Software 'SCALE PET' for Quantitative Analysis of Brain PET Images in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
The goal of this study is to learn if medical image analysis software, Neurophet SCALE PET, can enhance readers' amyloid beta positivity performance in people with Alzheimer's Disease. The main question it aims to answer is: Does the use of medical image analysis software assistance result in a statistically significant difference in readers' sensitivity and specificity for the classification of amyloid-β (Aβ) positivity? Four readers will interpret amyloid PET images in two sessions (with and without software assistance), separated by a 4-week washout period, and will record Aβ positivity and diagnostic confidence using predefined rating scales.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 11 Feb 2026
- Start date
- Jun 2025
- Primary completion date
- Nov 2025
- Lead sponsor
- NEUROPHET
- Diseases
- Alzheimer disease
- NCT number
- NCT07417540
What you commit to
- Study type: Interventional
- Participants enrolled: 190
- From Jun 2025 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of prior brain surgery resulting in significant structural changes, or presence of intracranial metallic implants.
Other
- Poor image quality due to artifacts, motion, shading, or other technical issues that make visual interpretation difficult or prevent proper software processing.
- Contrast-enhanced 3D T1-weighted brain MRI.
- Presence of structural brain lesions other than cerebral infarction.
- Cases deemed inappropriate for study participation at the investigator's discretion.
Who the study is looking for
- Age ≥ 50 years at the time of brain magnetic resonance imaging (MRI)
- Participants who underwent amyloid brain PET imaging using one of the following tracers: 18F-Florbetaben, 18F-Florbetapir, 18F-Flutemetamol
- Availability of 3D T1-weighted brain MRI.
- The interval between amyloid PET and 3D T1-weighted MRI is within 1 year.
- Participants meeting one of the following predefined groups based on prior visual interpretation of amyloid PET:
- Aβ-positive group: Prior clinical interpretation of amyloid PET reported as Aβ positive.
- Aβ-negative group: Prior clinical interpretation of amyloid PET reported as Aβ negative.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.