Parkinson's SyndromeNCT06856096
PET/MRI Artificial Intelligence Reconstruction Algorithm AIR Recon DL Image Quality Evaluation and Clinical Study
A study testing PET/MRI in people with Parkinson's Syndrome, run by Xijing Hospital at 1 site in China.
Trial summary
PET/MRI artificial intelligence reconstruction algorithm AIR Recon DL image quality evaluation and clinical study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Syndrome
- What is being tested?
- PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 15 Jan 2027
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adults between the ages of 18 and 75 who are autonomous; 2. persons with good compliance; 3. those who are mentally alert and able to move around on their own; 4. Those who agree to participate in this clinical trial and sign the informed consent form.
Who cannot join
- 1. Persons who do not have full capacity for civil behaviour; 2. Women during pregnancy and breastfeeding; 3. other implants, prostheses, foreign bodies and patches with electronic implants such as pacemakers, insulin pumps and cochlear implants that are not suitable for MRI; 4. patients with claustrophobia; 5. those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province
Xi'an, Shaanxi
About this study
PET/MRI artificial intelligence reconstruction algorithm AIR Recon DL image quality evaluation and clinical study
Read the detailed description
This is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases.
- Conditions
- Parkinson's Syndrome
- Being tested
- PET/MRI
- Keywords
- Artificial Intelligence Reconstruction Algorithms, AIR Recon DL, PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic test
PET/MR imaging using an integrated TOF PET/MR scanner (Signa, GE Healthcare, WI, USA)
| Study group | Role | What they receive |
|---|---|---|
| Comparison between different patients | Experimental | This is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases. Receives: Diagnostic Test: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to Noise Ratio
An important parameter for measuring image quality, indicating the ratio of signal to noise power
Measured: 1 day from injection of the tracer
Contrast to Noise Ratio
Describes the relative difference in signal strength between the two tissues, the greater the difference the better the image comparison
Measured: 1 day from injection of the tracer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start10 Feb 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Comparison between different patients
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856096
- Sponsor's protocol ID
- KY20252044
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MRI Artificial Intelligence Reconstruction Algorithm AIR Recon DL Image Quality Evaluation and Clinical Study
- ClinicalTrials.gov ID
- NCT06856096
- Acronym / sponsor ID
- KY20252044
- Conditions
- Parkinson's Syndrome
- Keywords
- Artificial Intelligence Reconstruction Algorithms, AIR Recon DL, PET/MRI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 4 Mar 2025 (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.
PET/MRI artificial intelligence reconstruction algorithm AIR Recon DL image quality evaluation and clinical study
Detailed description
This is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison between different patients
| Arm | Type | Receives |
|---|---|---|
| Comparison between different patients | Experimental | Diagnostic Test: PET/MRIThis is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adults between the ages of 18 and 75 who are autonomous; 2. persons with good compliance; 3. those who are mentally alert and able to move around on their own; 4. Those who agree to participate in this clinical trial and sign the informed consent form.
Key exclusion criteria (1 listed)
- 1. Persons who do not have full capacity for civil behaviour; 2. Women during pregnancy and breastfeeding; 3. other implants, prostheses, foreign bodies and patches with electronic implants such as pacemakers, insulin pumps and cochlear implants that are not suitable for MRI; 4. patients with claustrophobia; 5. those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRIPET/MR imaging using an integrated TOF PET/MR scanner (Signa, GE Healthcare, WI, USA) | Diagnostic test | Comparison between different patients |
Primary outcome
Signal to Noise Ratio
Time frame: 1 day from injection of the tracer
An important parameter for measuring image quality, indicating the ratio of signal to noise power
Contrast to Noise Ratio
Time frame: 1 day from injection of the tracer
Describes the relative difference in signal strength between the two tissues, the greater the difference the better the image comparison
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 4 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Parkinson's Syndrome, run by Xijing 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal to Noise Ratio (time frame: 1 day from injection of the tracer). The study lists 2 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 4 Mar 2025.