MedTrace Logo

Research on the Application of Sigma Radiopharmaceutical FBFP in Cerebral Stroke

NCT07558577 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-30

No results posted yet for this 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.

Conditions

  • Cerebral Ischemia
  • PET / MR

Interventions

DIAGNOSTIC_TEST

PET/MR multimodality imaging

Application research of Sigma imaging agent FBFP in stroke

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Jie Lu, Phd · Xuanwu Hospital of Capital Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558577 on ClinicalTrials.gov