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RecruitingNCT07079345PMQICUpdated Nov 20, 2025

PET/MR Multimodal Quantitative Analysis of CBF and CMRGlc in Cerebral Ischemia

An observational study in PET/MR and Stroke Ischemic, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Xuanwu Hospital, Beijing · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
Male
01

Study 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, 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:

  1. Study Type: Observational study
  2. 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.
  3. Sample Size: 200 patients with cephalic and carotid atherosclerotic stenosis.
  4. Observation Indicators: Distribution patterns of cerebral blood flow and metabolic reduction areas in patients; correlation analysis between blood flow, metabolic values and clinical scores.
  5. 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.
02

Conditions studied

  • PET/MR
  • Stroke Ischemic

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient with intracranial artery stenosis due to head and carotid atherosclerosis

Inclusion criteria

  1. 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;
  2. 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;
  3. MRI showed no new infarct lesions in the skull;
  4. There is no infarct lesion in the previous pontine area;
  5. Research participants and informants can complete relevant examinations and follow-ups;
  6. Informed consent signed by the study participant or his/her authorized representative;

Exclusion criteria

Exclusion Criteria:

  1. Poor image quality caused by head movement or other reasons during scanning
  2. 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.)
  3. 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
  4. Presence of other known diseases that may cause cognitive impairmentPresence of other known diseases that may cause cognitive impairment
  5. Individuals with severe visual or hearing impairment, claustrophobia, or other conditions that prevent cooperation with MRI examination
  6. Individuals suffering from diseases that make it impossible to cooperate with cognitive examinations
  7. Refusal to sign the informed consent form at baseline
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Group 1
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: CBF and CMRGlc at 6 months post-treatment

  2. 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

    Time frame: CBF and CMRGlc at 6 months post-treatment

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Study locations

1 of 1 sites recruiting
  • Xuanwu Hospitail, Capital Medical University
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07079345
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Jul 23, 2025
Start date
Jul 1, 2025
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Nov 20, 2025

Study contacts

Bixiao Cui
Contact
bixiao1311@163.com
86-18311281311

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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