68Ga-FAPI PET/MR for Atherosclerosis

NCT ID: NCT05036759

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-08-30

Brief Summary

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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

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

68Ga-FAPI PET/MR
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-FAPI, PET/MR

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

Group Type EXPERIMENTAL

68Ga-FAPI

Intervention Type DRUG

intravenously injected with 68Ga-FAPI

Interventions

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68Ga-FAPI

intravenously injected with 68Ga-FAPI

Intervention Type DRUG

Other Intervention Names

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68Ga-fibroblast activating protein inhibitors

Eligibility Criteria

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Inclusion Criteria

* intracranial or carotid atherosclerosis patients
* signed informed consent

Exclusion Criteria

* pregnancy, breastfeeding
* contradictions of MRI
* unstable vital signs
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiao Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Meiqi Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Huo, M.D.

Role: CONTACT

86-10-69155537

Facility Contacts

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Li Huo

Role: primary

86-10-69155513

Other Identifiers

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PUMCH-FAPI-PET/MR

Identifier Type: -

Identifier Source: org_study_id

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