Paediatric PatientsNCT06709690
A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases
An observational study of Paediatric Patients, run by Ruijin Hospital at 1 site in China.
Trial summary
To investigate the feasibility of deep learning-assisted rapid silent PET/MR in pediatric applications. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Paediatric Patients
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China, Shanghai Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, 200001
Wenli Lu, 13621957831, lwl11146@rjh.com.cn
About this study
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.
- Conditions
- Paediatric Patients
- Keywords
- 18F-FDG PET/MR, pediatric, silent scan, flexible coil, deep learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Completion of PET/MR examinations
Upon completion of the examination, record the rate of completion
Measured: 1 year
Sedation during PET/MR examinations
Upon completion of the examination, record the rate of sedation and rate of secondary sedation
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start25 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric PatientsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709690
- Sponsor's protocol ID
- RuijinH 2024-467
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases
- ClinicalTrials.gov ID
- NCT06709690
- Acronym / sponsor ID
- RuijinH 2024-467
- Conditions
- Paediatric Patients
- Keywords
- 18F-FDG PET/MR, pediatric, silent scan, flexible coil, deep learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Completion of PET/MR examinations
Time frame: 1 year
Upon completion of the examination, record the rate of completion
Sedation during PET/MR examinations
Time frame: 1 year
Upon completion of the examination, record the rate of sedation and rate of secondary sedation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Patients, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajia Hu (13524945287, jiajiahu@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion detection rate (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.