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

NCT06856096 | Active Not Recruiting

• 1 other identifier: KY20252044
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

PET/MRI artificial intelligence reconstruction algorithm AIR Recon DL image quality evaluation and clinical study

Conditions

Parkinson's Syndrome

Keywords

Artificial Intelligence Reconstruction Algorithms; AIR Recon DL; PET/MRI

Outcome Measures

Primary Outcomes (2)

• Signal to Noise Ratio

  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

  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

Study Arms (1)

Comparison between different patients

EXPERIMENTAL

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

Interventions

PET/MRI DIAGNOSTIC_TEST

PET/MR imaging using an integrated TOF PET/MR scanner (Signa, GE Healthcare, WI, USA)

Comparison between different patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

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

Xi'an, Shaanxi, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between different patients

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)