68Ga-FAPI PET/MR for Atherosclerosis

September 6, 2021 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Qiao Yang, M.D.
        • Principal Investigator:
          • Meiqi Wu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • intracranial or carotid atherosclerosis patients
  • signed informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 68Ga-FAPI, PET/MR
inject 68Ga-FAPI，and then perform PET/MR
Drug: 68Ga-FAPI
intravenously injected with 68Ga-FAPI
Other Names:
  • 68Ga-fibroblast activating protein inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance
Time Frame: through study completion, an average of 2 years
Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax
Time Frame: through study completion, an average of 2 years
The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients
through study completion, an average of 2 years
FAPI expression
Time Frame: through study completion, an average of 2 years
The correlation of SUVmax and pathological FAPI expression
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Qiao Yang, M.D., Peking Union Medical College Hospital
  • Principal Investigator: Meiqi Wu, M.D., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 26, 2021

Primary Completion (ANTICIPATED)

August 30, 2023

Study Completion (ANTICIPATED)

August 30, 2023

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (ACTUAL)

September 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-FAPI-PET/MR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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