Clincosm LogoSign in Get a demo

68Ga-FAPI PET/MR for Atherosclerosis

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05036759
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
27.1
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
68Ga-FAPI PET/MR68Ga-FAPI PET/MR
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-FAPI, PET/MR

inject 68Ga-FAPIļ¼Œand then perform PET/MR

Drug: 68Ga-FAPI
intravenously injected with 68Ga-FAPI
Other Names:
  • 68Ga-fibroblast activating protein inhibitors

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. SUVmax [through study completion, an average of 2 years]

      The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients

    2. FAPI expression [through study completion, an average of 2 years]

      The correlation of SUVmax and pathological FAPI expression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • intracranial or carotid atherosclerosis patients

    • signed informed consent

    Exclusion Criteria:

    • pregnancy, breastfeeding

    • contradictions of MRI

    • unstable vital signs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China 100005

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05036759
    Other Study ID Numbers:
    • PUMCH-FAPI-PET/MR
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    atherosclerosis
    68Ga-FAPI
    PET/MR
    Additional relevant MeSH terms:
    Atherosclerosis

    Study Results

    No Results Posted as of Sep 8, 2021