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68Ga-FAPI PET/MR for Atherosclerosis

68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05036759
Enrollment
100
Registered
2021-09-08
Start date
2021-05-26
Completion date
2023-08-30
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

atherosclerosis, 68Ga-FAPI, PET/MR

Brief summary

A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Detailed description

A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Previous ex vivo analysis of human aortic atheromata revealed that FAP was expressed in atherosclerotic plaques, and higher FAP expression was detected in thin fibrous caps than thick caps. Constitutive Fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Interventions

intravenously injected with 68Ga-FAPI

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

68Ga-FAPI PET/MR

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* intracranial or carotid atherosclerosis patients * signed informed consent

Exclusion criteria

* pregnancy, breastfeeding * contradictions of MRI * unstable vital signs

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performancethrough study completion, an average of 2 yearsDiagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis

Secondary

MeasureTime frameDescription
SUVmaxthrough study completion, an average of 2 yearsThe difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients
FAPI expressionthrough study completion, an average of 2 yearsThe correlation of SUVmax and pathological FAPI expression

Countries

China

Contacts

Primary ContactLi Huo, M.D.
huoli@pumch.cn86-10-69155537

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026