PET/MRPMQICNCT07079345
PET/MR Multimodal Quantitative Analysis of CBF and CMRGlc in Cerebral Ischemia
An observational study of PET/MR and Stroke Ischemic, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Research Purpose: This project focuses on clinical research issues in the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis. Through multimodal imaging technology, it aims to optimize non-invasive quantitative algorithm models for cerebral blood flow and cerebral metabolism… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- PET/MR, Stroke Ischemic
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Aug 2028
- How long will I take part?
- 6 Months
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patient with intracranial artery stenosis due to head and carotid atherosclerosis
Who may be able to join
- Angiography diagnosed unilateral anterior circulation head carotid artery stenosis, the diameter of the tube was reduced by >70%, and the contralateral anterior circulation and bilateral posterior circulation did not exceed the stenosis of >50% of the diameter reduction;
- Must have had a transient ischemic attack or ischemic stroke within the area of the diseased vessel within the past 12 months, with the most recent onset being more than 3 weeks;
- MRI showed no new infarct lesions in the skull;
- There is no infarct lesion in the previous pontine area;
- Research participants and informants can complete relevant examinations and follow-ups;
- Informed consent signed by the study participant or his/her authorized representative;
Who cannot join
- Poor image quality caused by head movement or other reasons during scanning
- Presence of other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus, etc.)
- Presence of other systemic diseases that can cause cognitive impairment, such as hepatic insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid and vitamin B12 deficiency, specific infections (such as syphilis, HIV), alcohol and drug abuse, etc
- Presence of other known diseases that may cause cognitive impairmentPresence of other known diseases that may cause cognitive impairment
- Individuals with severe visual or hearing impairment, claustrophobia, or other conditions that prevent cooperation with MRI examination
- Individuals suffering from diseases that make it impossible to cooperate with cognitive examinations
- Refusal to sign the informed consent form at baseline
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
Xuanwu Hospitail, Capital Medical University
Beijing
Bixiao Cui, 86-18311281311, bixiao1311@163.com
About this study
Official title: PET/MR Multimodal Quantitative Imaging of Cerebral Ischemia With CBF and CMRGlc Assessment in Cephalo-Carotid Atherosclerosis
Research Purpose:
This project focuses on clinical research issues in the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis. Through multimodal imaging technology, it aims to optimize non-invasive quantitative algorithm models for cerebral blood flow and cerebral metabolism, explore new imaging markers, and investigate quantitative indicators of cerebral blood flow and metabolism for the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis undergoing drug therapy or surgical treatment.
Read more
Research Design:
- Study Type: Observational study
- Study Subjects: In accordance with the *Chinese Clinical Management Guidelines for Cerebrovascular Diseases (2nd Edition)*, patients with cephalic and carotid atherosclerotic stenosis admitted to the department of neurosurgery will be enrolled. Data collection time points are at enrollment, 6-month follow-up, and 12-month follow-up.
- Sample Size: 200 patients with cephalic and carotid atherosclerotic stenosis.
- Observation Indicators: Distribution patterns of cerebral blood flow and metabolic reduction areas in patients; correlation analysis between blood flow, metabolic values and clinical scores.
- Statistical Analysis Methods: Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) version 21.0. All statistical results will be expressed as mean ± standard deviation. First, the Shapiro-Wilk test will be used to assess normal distribution. Under the premise of normal distribution, paired t-test will be used to compare blood flow and metabolic values between the lesion area and the contralateral area of patients, as well as to compare changes in blood flow and metabolism of patients at different time points. Pearson correlation analysis will be used to analyze the relationship between blood flow/metabolic parameters and clinical neurological function scores. The Mann-Whitney U test will be used to analyze variables with non-normal distribution. A P value < 0.05 will be considered statistically significant.
- Conditions
- PET/MR, Stroke Ischemic
- Medical subject headings
- Ischemic Stroke
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 |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the cerebral blood flow (CBF, mL 100g-1 min-1) at 6 Months
Results of integrated PET/MR examination at 6 months post-treatment
Measured: CBF and CMRGlc at 6 months post-treatment
Change from Baseline in the cerebral metabolic rate of glucose (CMRglc, μmol 100g-1 min-1) at 6 Months
Results of integrated PET/MR examination at 6 months post-treatment
Measured: CBF and CMRGlc at 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET/MRStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079345
- Sponsor's protocol ID
- LYS[2025]201-001
- Other IDs
- 2024ZD0539800
- Acronym
- PMQIC
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 20 Nov 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MR Multimodal Quantitative Imaging of Cerebral Ischemia With CBF and CMRGlc Assessment in Cephalo-Carotid Atherosclerosis
- ClinicalTrials.gov ID
- NCT07079345
- Acronym / sponsor ID
- PMQIC / LYS[2025]201-001
- Conditions
- PET/MR, Stroke Ischemic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 23 Jul 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.
Research Purpose:
This project focuses on clinical research issues in the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis. Through multimodal imaging technology, it aims to optimize non-invasive quantitative algorithm models for cerebral blood flow and cerebral metabolism, explore new imaging markers, and investigate quantitative indicators of cerebral blood flow and metabolism for the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis undergoing drug therapy or surgical treatment.
Research Design:
- Study Type: Observational study
- Study Subjects: In accordance with the *Chinese Clinical Management Guidelines for Cerebrovascular Diseases (2nd Edition)*, patients with cephalic and carotid atherosclerotic stenosis admitted to the department of neurosurgery will be enrolled. Data collection time points are at enrollment, 6-month follow-up, and 12-month follow-up.
- Sample Size: 200 patients with cephalic and carotid atherosclerotic stenosis.
- Observation Indicators: Distribution patterns of cerebral blood flow and metabolic reduction areas in patients; correlation analysis between blood flow, metabolic values and clinical scores.
- Statistical Analysis Methods: Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) version 21.0. All statistical results will be expressed as mean ± standard deviation. First, the Shapiro-Wilk test will be used to assess normal distribution. Under the premise of normal distribution, paired t-test will be used to compare blood flow and metabolic values between the lesion area and the contralateral area of patients, as well as to compare changes in blood flow and metabolism of patients at different time points. Pearson correlation analysis will be used to analyze the relationship between blood flow/metabolic parameters and clinical neurological function scores. The Mann-Whitney U test will be used to analyze variables with non-normal distribution. A P value < 0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with intracranial artery stenosis due to head and carotid atherosclerosis
Key inclusion criteria (6 listed)
- Angiography diagnosed unilateral anterior circulation head carotid artery stenosis, the diameter of the tube was reduced by >70%, and the contralateral anterior circulation and bilateral posterior circulation did not exceed the stenosis of >50% of the diameter reduction;
- Must have had a transient ischemic attack or ischemic stroke within the area of the diseased vessel within the past 12 months, with the most recent onset being more than 3 weeks;
- MRI showed no new infarct lesions in the skull;
- There is no infarct lesion in the previous pontine area;
- Research participants and informants can complete relevant examinations and follow-ups;
Key exclusion criteria (7 listed)
- Poor image quality caused by head movement or other reasons during scanning
- Presence of other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus, etc.)
- Presence of other systemic diseases that can cause cognitive impairment, such as hepatic insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid and vitamin B12 deficiency, specific infections (such as syphilis, HIV), alcohol and drug abuse, etc
- Presence of other known diseases that may cause cognitive impairmentPresence of other known diseases that may cause cognitive impairment
- Individuals with severe visual or hearing impairment, claustrophobia, or other conditions that prevent cooperation with MRI examination
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
Change from Baseline in the cerebral blood flow (CBF, mL 100g-1 min-1) at 6 Months
Time frame: CBF and CMRGlc at 6 months post-treatment
Results of integrated PET/MR examination at 6 months post-treatment
Change from Baseline in the cerebral metabolic rate of glucose (CMRglc, μmol 100g-1 min-1) at 6 Months
Time frame: CBF and CMRGlc at 6 months post-treatment
Results of integrated PET/MR examination at 6 months post-treatment
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 20 Nov 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.
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 PET/MR and Stroke Ischemic, run by Xuanwu Hospital, Beijing 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 6 inclusion and 7 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 20 Nov 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?
Contact Bixiao Cui (86-18311281311, bixiao1311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the cerebral blood flow (CBF, mL 100g-1 min-1) at 6 Months (time frame: CBF and CMRGlc at 6 months post-treatment). 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 20 Nov 2025.