68Ga-FAPI PET/MR for Atherosclerosis

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036759
• Other study ID #: PUMCH-FAPI-PET/MR
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 26, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2021
• Source: Peking Union Medical College Hospital
• Contact: Li Huo, M.D.
• Phone: 86-10-69155537
• Email: huoli[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• intracranial or carotid atherosclerosis patients
• signed informed consent

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• 68Ga-FAPI
intravenously injected with 68Ga-FAPI

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance	Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis	through study completion, an average of 2 years
Secondary	SUVmax	The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients	through study completion, an average of 2 years
Secondary	FAPI expression	The correlation of SUVmax and pathological FAPI expression	through study completion, an average of 2 years