NCT05036759

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2021

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 30, 2021

Last Update Submit

September 6, 2021

Conditions

Atherosclerosis

Keywords

atherosclerosis68Ga-FAPIPET/MR

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance

    Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis

    through study completion, an average of 2 years

Secondary Outcomes (2)

  • SUVmax

    through study completion, an average of 2 years

  • FAPI expression

    through study completion, an average of 2 years

Study Arms (1)

68Ga-FAPI, PET/MR

EXPERIMENTAL

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

Drug: 68Ga-FAPI

Interventions

68Ga-FAPIDRUG

intravenously injected with 68Ga-FAPI

Also known as: 68Ga-fibroblast activating protein inhibitors
68Ga-FAPI, PET/MR

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intracranial or carotid atherosclerosis patients
  • signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100005, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Qiao Yang, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

  • Meiqi Wu, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Huo, M.D.

CONTACT

86-10-69155537huoli@pumch.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 68Ga-FAPI PET/MR
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 8, 2021

Study Start

May 26, 2021

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)