Back to results68Ga-FAPI PET/MR for Atherosclerosis
Primary Purpose
Atherosclerosis
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
About this trial
This is an interventional diagnostic trial for Atherosclerosis focused on measuring atherosclerosis, 68Ga-FAPI, PET/MR
Eligibility Criteria
Inclusion Criteria:
- intracranial or carotid atherosclerosis patients
- signed informed consent
Exclusion Criteria:
- pregnancy, breastfeeding
- contradictions of MRI
- unstable vital signs
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI, PET/MR
Arm Description
inject 68Ga-FAPI，and then perform PET/MR
Outcomes
Primary Outcome Measures
Diagnostic performance
Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis
Secondary Outcome Measures
SUVmax
The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients
FAPI expression
The correlation of SUVmax and pathological FAPI expression
Full Information
NCT ID
NCT05036759
First Posted
August 30, 2021
Last Updated
September 6, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05036759
Brief Title
68Ga-FAPI PET/MR for Atherosclerosis
Official Title
68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
atherosclerosis, 68Ga-FAPI, PET/MR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
68Ga-FAPI PET/MR
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI, PET/MR
Arm Type
Experimental
Arm Description
inject 68Ga-FAPI，and then perform PET/MR
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitors
Intervention Description
intravenously injected with 68Ga-FAPI
Primary Outcome Measure Information:
Title
Diagnostic performance
Description
Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
SUVmax
Description
The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients
Time Frame
through study completion, an average of 2 years
Title
FAPI expression
Description
The correlation of SUVmax and pathological FAPI expression
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
intracranial or carotid atherosclerosis patients
signed informed consent
Exclusion Criteria:
pregnancy, breastfeeding
contradictions of MRI
unstable vital signs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, M.D.
Phone
86-10-69155537
Email
huoli@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiao Yang, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meiqi Wu, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Huo
Phone
86-10-69155513
Email
huoli@pumch.cn
First Name & Middle Initial & Last Name & Degree
Qiao Yang, M.D.
First Name & Middle Initial & Last Name & Degree
Meiqi Wu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga-FAPI PET/MR for Atherosclerosis
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