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

NCT06709690 | Recruiting DMC

• 1 other identifier: RuijinH 2024-467
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paediatric Patients

Keywords

18F-FDG PET/MR; pediatric; silent scan; flexible coil; deep learning

Outcome Measures

Primary Outcomes (4)

• Lesion detection rate

  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.

  1 year

• Completion of PET/MR examinations

  Upon completion of the examination, record the rate of completion

  1 year

• Sedation during PET/MR examinations

  Upon completion of the examination, record the rate of sedation and rate of secondary sedation

  1 year

• Qualitative image quality

  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.

  1 year

Study Arms (1)

Paediatric patients

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

You may qualify if:

• 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.
• Signed and dated informed consent form
• Commit to complying with the research procedures and cooperate in the implementation of the entire research process.
• No gender restriction, aged between 0 and 18 years old.

You may not qualify if:

• 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.
• Patients with severe claustrophobia，epileptic seizures, respiratory distress who cannot lie down, and patients with mental anomalies who are unable to cooperate.
• Patients with metal implants such as pacemakers, artificial metal heart valves, and neurostimulators in their bodies.
• Non-compliant person.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Central Study Contacts

Jiajia Hu

CONTACT

13524945287; jiajiahu@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 29, 2024
• Study Start: October 25, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)