NCT05020626

Brief Summary

The most significant impact of this project is to propose for the first time a novel generative adversarial network (GAN), as one kind of deep learning architecture, to automatically generate synthetic PET images reflecting tau deposition, from brain DTI images. If successful, this framework will become the most state-of-the-art approach to simulate the stereotypical pattern of intracerebral tau accumulation and distribution in vivo. Synthetic tau-PET images via DTI, possessing overwhelming superiority in radiation-free, non-invasiveness and cost-effectiveness, will potentially serve as one of alternative modalities of PET in detecting tau-load and probably outperform PET on accessibility, generalizability, and availability in future, making it much more attractive in clinical application. A big conceptual shift may occur preferring a fire-new tau-PET simulated via DTI. The DTI data-driven deep learning framework to be created in this project will constitute an accurate, robust, clinically applicable and explainable tool to efficiently categorize the subjects into tau-burden positive and tau-burden negative cases, which will undoubtedly contribute to both clinical and research activities.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

August 4, 2021

Last Update Submit

August 21, 2024

Conditions

Keywords

Generative Adversarial NetworkTauDiffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

  • Structural similarity index to measure the similarity between synthetic image and ground truth for 20% of data in testing set

    Through study completion, an average of 1 year

Study Arms (3)

Controls

Mild cognitive impairment

AD dementia

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The data will be collected from a public database, i.e, Alzheimer's Disease Nueroimaging Initiative (ADNI). According to their recruitment protocol at http://adni.loni.usc.edu/methods/documents/, the study enrolls men and women aged 55-90 years across MCI and mild AD dementia participant groups, and control normal aged 65 years with exceptions granted for minority participants.

You may qualify if:

  • With the age of 55 years and above
  • With brain MRI taken within ±6 months from the date of clinically confirmed diagnosis of AD, MCI or normal cognition.

You may not qualify if:

  • AD with mixed dementia
  • Non-AD dementia
  • History of severe traumatic brain injury, severe depression, stroke, brain tumors, and incident major systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Frontotemporal DementiaFrontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 25, 2021

Study Start

June 30, 2021

Primary Completion

June 29, 2025

Study Completion

December 31, 2025

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations