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Not yet recruitingNCT07558577Updated Apr 30, 2026

Research on the Application of Sigma Radiopharmaceutical FBFP in Cerebral Stroke

An interventional study of PET/MR multimodality imaging in Cerebral Ischemia and PET / MR, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

This clinical research, aims to investigate the uptake of [18F]FBFP, a Sigma-1 receptor (Sig 1R) PET imaging agent, in stroke participants, compare differences with healthy controls, and evaluate its diagnostic efficacy, providing objective basis for clinical diagnosis and treatment.

The study will recruit 30 stroke participants (with specific inclusion criteria for unilateral ICA stenosis cases) and 20 gender- and age-matched healthy controls from January 2025 to December 2026. Exclusion criteria cover various neurological and systemic diseases that may affect results, as well as conditions preventing cooperation with examinations.

No intervention measures are involved. Follow-ups will be conducted at 6 and 12 months to collect clinical data and observe neurological symptom progression. Key measurements include clinical information (via questionnaires and scales like NIHSS and mRS) and PET/MR imaging data (analyzed using PMOD software to calculate SUVmean and uptake differences with cerebellar cortex as reference).

Statistical analysis will use SPSS 21.0, applying descriptive statistics, t-test, ANOVA, regression models, ROC curves, etc., with P \< 0.05 as significant. Safety evaluation notes PET/MR radiation dose (3-5mSv) is much lower than the safe threshold.

Participant protection includes ethical approval, informed consent, voluntary participation, risk disclosure, no fees for related exams, and privacy protection. The research team and institution have sufficient resources and qualifications, with outputs including a clinical research cohort and a high-quality paper.

02

Conditions studied

  • Cerebral Ischemia
  • PET / MR

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03

In context

Brain Ischemia

217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.

This study's planned enrollment of 50 is below the median of 73 across 140 interventional studies indexed under Brain Ischemia.

Browse Brain Ischemia studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.

Browse Xuanwu Hospital, Beijing studies →

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

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Angiography diagnosis shows unilateral anterior circulation head and neck artery stenosis with a diameter reduction of>70%, and there is no stenosis in the contralateral anterior circulation or bilateral posterior circulation with a diameter reduction of>50%;
  2. or ischemic stroke that must have occurred within the past 12 months in the affected vascular area, with the most recent attack lasting more than 3 weeks;
  3. MRI shows no new intracranial infarction lesions;
  4. No previous infarction lesions in the pontine area;
  5. Either PET/MR blood flow or metabolic imaging shows reduced blood flow and metabolism in the affected hemisphere, with a reduction rate exceeding 10% compared to the contralateral region;
  6. Subjects and informants can complete relevant examinations and follow-up work;
  7. The subject or their authorized representative signs the form.

Exclusion criteria

Exclusion Criteria:

  1. Poor image quality due to head movement and other reasons during the scanning process.
  2. There are other neurological disorders that can cause brain dysfunction, such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.
  3. There are other systemic diseases that can cause cognitive impairment, such as liver dysfunction, kidney dysfunction, thyroid dysfunction, severe anemia, folate and vitamin B12 deficiency, special infections (such as syphilis, ), alcohol and drug abuse, etc.
  4. Existence of mental and neurological developmental delay.
  5. There are other known diseases that may cause cognitive impairment.
  6. Individuals with severe visual and hearing impairments, claustrophobia, and other conditions who cannot cooperate with MRI examinations.
  7. Suffering from diseases that prevent cooperation in completing cognitive examinations.
  8. Refusal to sign form during baseline period -
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Heath control

    Heath control received intravenous injection of \[18F\]FBFP PET/MR under standardized conditions.

  • Experimental
    Stroke group

    Stroke patients received intravenous injection of \[18F\]FBFP PET/MR under standardized conditions.

    Diagnostic Test: PET/MR multimodality imaging

Interventions

  • Diagnostic testPET/MR multimodality imaging

    Application research of Sigma imaging agent FBFP in stroke

06

What researchers measure

Primary outcomes

  1. Brain metabolic value

    Quantitative detection was performed using an integrated PET/MR scanner. After injecting FBFP at a dose of 1.8 MBq/kg (0.05 mCi/kg), the PET/MR synchronous scan was initiated 60 minutes later and lasted for 30 minutes. Data were collected through a 19-channel head-neck combined coil.

    Time frame: PET/MR examinationDuring MR examination, PET examination was conducted simultaneously. Follow-up visits were conducted at 6 months and 12 months after the examination, including general clinical data of the patients, clinical symptoms, and clinical score

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.

Of 43 interventional studies with no phase under Brain Ischemia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2025
First posted
Apr 30, 2026
StartEst.
Jun 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Apr 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07558577
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 30, 2026

Study contacts

Jie Lu, Phd
Contact
imaginglu@hotmail.com
+86 13309824318
Jie Lu, Phd
principal investigator · Xuanwu Hospital of Capital Medical University

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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