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

November 25, 2024 updated by: Ruijin Hospital
To investigate the feasibility of deep learning-assisted rapid silent PET/MR in pediatric applications.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Recruiting
        • China, Shanghai Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
        • Contact:

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion detection rate
Time Frame: 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.
1 year
Completion of PET/MR examinations
Time Frame: 1 year
Upon completion of the examination, record the rate of completion
1 year
Sedation during PET/MR examinations
Time Frame: 1 year
Upon completion of the examination, record the rate of sedation and rate of secondary sedation
1 year
Qualitative image quality
Time Frame: 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.
1 year

Collaborators and Investigators

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

Sponsor

Ruijin 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)

October 25, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RuijinH 2024-467

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

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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