A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases

Recruiting

• Conditions: Paediatric Patients

• Registration Number: NCT06709690
• Lead Sponsor: Ruijin Hospital

Brief Summary

To investigate the feasibility of deep learning-assisted rapid silent PET/MR in pediatric applications.

Detailed Description

This study aims to address the challenges faced by PET/MR in pediatric applications by leveraging new technologies such as flexible coils, silent sequences, and deep learning-based image reconstruction. The objective is to provide a rapid, silent, comfortable, and half-dose PET/MR imaging solution for pediatric patients, and to demonstrate its feasibility in this patient population.

Study Timeline

• Study Start: 2024-10-25
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Children who have clinical symptoms and are suspected of having malignant tumors after being evaluated by clinical pediatricians and require 18F-FDG PET/MR examination to further clarify their conditions.
2. Signed and dated informed consent form
3. Commit to complying with the research procedures and cooperate in the implementation of the entire research process.
4. No gender restriction, aged between 0 and 18 years old.

Exclusion Criteria

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Patients with severe claustrophobia，epileptic seizures, respiratory distress who cannot lie down, and patients with mental anomalies who are unable to cooperate.
3. Patients with metal implants such as pacemakers, artificial metal heart valves, and neurostimulators in their bodies.
4. Non-compliant person.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lesion detection rate	1 year	Routine laboratory or imaging tests or pathology are performed based on clinical needs to assess the accuracy, sensitivity and specificity of rapid silent 18F-FDG PET/MR for lesion detection.
Completion of PET/MR examinations	1 year	Upon completion of the examination, record the rate of completion
Sedation during PET/MR examinations	1 year	Upon completion of the examination, record the rate of sedation and rate of secondary sedation
Qualitative image quality	1 year	Two experienced nuclear medicine physicians evaluated the overall quality of the images using a Likert 5-point scale for both the new imaging PET/MR protocol and the traditional imaging protocol.

Trial Locations

Locations (1)

China, Shanghai Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine; 🇨🇳 Shanghai, Shanghai, China