Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease

NCT07417540 | Completed DMC

• 1 other identifier: AJOUIRB-DE-2025-195
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI)

Keywords

Alzheimer's Disease; Amyloid-β (Aβ); brain PET; quantification; AI software; reader study; Multi-Reader Multi-Case (MRMC); Centiloid Scale; SUVR

Outcome Measures

Primary Outcomes (2)

• Difference in readers' sensitivity in SW-assisted vs. unassisted classification of Aβ positivity

  Comparison of the sensitivity for amyloid-beta positivity between the software-assisted and unassisted reading conditions, based on the expert-established reference standard.

  At the completion of two reading sessions (approximately 3 months)

• Difference in readers' specificity in SW-assisted vs. unassisted classification of Aβ positivity

  Comparison of the specificity for amyloid-beta negativity between the software-assisted and unassisted reading conditions, based on the expert-established reference standard.

  At the completion of the reading study (approximately 3 months)

Secondary Outcomes (4)

• Difference in readers' diagnostic accuracy in SW-assisted vs. unassisted classification of Aβ positivity

  At the completion of the reading study (approximately 3 months)

• Difference in number of cases rated as equivocal in SW-assisted vs. unassisted classification of Aβ positivity

  At the completion of the reading study (approximately 3 months)

• Difference in confidence level of readers in SW-assisted vs. unassisted classification of Aβ positivity

  At the completion of the reading study (approximately 3 months)

• Inter-rater Agreement

  At the completion of the reading study (approximately 3 months)

Other Outcomes (1)

• Number of analysis failure cases

  At the completion of the reading study (approximately 3 months)

Study Arms (2)

Reader group 1

EXPERIMENTAL

In Session 1, readers in this group interpret Case Group A with software (SW) assistance and Case Group B without assistance (visual read). Following a 4-week washout period, the conditions are swapped for Session 2: readers interpret Case Group A without SW assistance and Case Group B with SW assistance.

Device: Neurophet SCALE PET

Reader group 2

EXPERIMENTAL

In Session 1, readers in this group interpret Case Group B with software (SW) assistance and Case Group A without assistance (visual read). Following a 4-week washout period, the conditions are swapped for Session 2: readers interpret Case Group B without SW assistance and Case Group A with SW assistance.

Device: Neurophet SCALE PET

Interventions

Neurophet SCALE PET DEVICE

Neurophet SCALE PET is an artificial intelligence-based medical image analysis software designed for the quantitative analysis of brain PET images. It provides automated quantification of amyloid-beta (Aβ) deposition using standardized uptake value ratios (SUVR) and the Centiloid scale. In this study, the software is used as a diagnostic support tool to assist clinicians in evaluating Aβ positivity.

Reader group 1; Reader group 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Poor image quality due to artifacts, motion, shading, or other technical issues that make visual interpretation difficult or prevent proper software processing.
• Presence of prior brain surgery resulting in significant structural changes, or presence of intracranial metallic implants.
• 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.

Sponsors & Collaborators

• NEUROPHET: lead
• Ajou University Hospital, Suwon, South Korea: collaborator

Study Sites (1)

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Soyoung Moon

  Department of Neurology, Ajou University School of Medicine, Suwon, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The four readers participating in the study are blinded to the subjects' clinical information and the expert-determined reference standards for amyloid-beta positivity. This masking is maintained throughout both reading sessions to prevent bias in diagnostic performance evaluation.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: June 2, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)