68Ga-FAPI PET/MR for Atherosclerosis

Early Phase 1

• Conditions: Atherosclerosis
• Interventions: Drug: 68Ga-FAPI

• Registration Number: NCT05036759
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2021-05-26
• Status Verified: 2021-08
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-08
• Last Update Posted: 2021-09-08
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• intracranial or carotid atherosclerosis patients
• signed informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI, PET/MR	68Ga-FAPI	inject 68Ga-FAPI，and then perform PET/MR

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	through study completion, an average of 2 years	Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis

Secondary Outcome Measures

Name	Time	Method
SUVmax	through study completion, an average of 2 years	The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients
FAPI expression	through study completion, an average of 2 years	The correlation of SUVmax and pathological FAPI expression

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China