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RecruitingNCT06709690Updated Nov 29, 2024

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

An observational study in Paediatric Patients, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
35
Ages
Up to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Paediatric Patients

Keywords

  • 18F-FDG PET/MR
  • pediatric
  • silent scan
  • flexible coil
  • deep learning
03

In context

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
35 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. Completion of PET/MR examinations

    Upon completion of the examination, record the rate of completion

    Time frame: 1 year

  3. Sedation during PET/MR examinations

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

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • China, Shanghai Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
    Shanghai, Shanghai 200001, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06709690
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Oct 25, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Jiajia Hu
Contact
jiajiahu@shsmu.edu.cn
13524945287

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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