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NCT Number: NCT06709690

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

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

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Key information

Conditions

Paediatric Patients

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200001, China

Location status: Recruiting

Location contact

Wenli Lu

CONTACT

[email protected]

13621957831

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Completion of PET/MR examinations

    Time frame: 1 year

    Upon completion of the examination, record the rate of completion

  3. Sedation during PET/MR examinations

    Time frame: 1 year

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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Hu

CONTACT

[email protected]

13524945287

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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