PET/MRI Artificial Intelligence Reconstruction Algorithm AIR Recon DL Image Quality Evaluation and Clinical Study

February 26, 2025 updated by: Xijing Hospital
PET/MRI artificial intelligence reconstruction algorithm AIR Recon DL image quality evaluation and clinical study

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Adults between the ages of 18 and 75 who are autonomous; 2. persons with good compliance; 3. those who are mentally alert and able to move around on their own; 4. Those who agree to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

  • 1. Persons who do not have full capacity for civil behaviour; 2. Women during pregnancy and breastfeeding; 3. other implants, prostheses, foreign bodies and patches with electronic implants such as pacemakers, insulin pumps and cochlear implants that are not suitable for MRI; 4. patients with claustrophobia; 5. those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparison between different patients
This is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases.
Diagnostic test: PET/MRI
PET/MR imaging using an integrated TOF PET/MR scanner (Signa, GE Healthcare, WI, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to Noise Ratio
Time Frame: 1 day from injection of the tracer
An important parameter for measuring image quality, indicating the ratio of signal to noise power
1 day from injection of the tracer
Contrast to Noise Ratio
Time Frame: 1 day from injection of the tracer
Describes the relative difference in signal strength between the two tissues, the greater the difference the better the image comparison
1 day from injection of the tracer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY20252044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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