Menu
Recruiting NCT07107919

Multimodal Imaging Assessment of Chronic Kidney Disease Patients at Different Stages From a Cardio-Renal Interaction Perspective

— Observational Chronic Kidney Disease Cardiac Magnetic Resonance 18F-FAPI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F PET/MR.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease, Cardiac Magnetic Resonance, 18F-FAPI. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is a prospective cohort investigation in which consecutive eligible patients undergo 18F-FAPI PET/MR imaging. Chronic kidney disease (CKD) participants are stratified into two groups:Group I ：CKD stages 1-3（eGFR ≥ 30 mL/min/1.73 m²）,Group II :CKD stages 4-5(eGFR \< 30 mL/min/1.73 m²). Using 18F-FAPI PET/MR, we will evaluate global cardiac functional impairment and myocardial fibrosis characteristics, and analyze their associations with the degree of renal dysfunction.

Interventions

  • Other 18F PET/MR
    Tracer: \^18F FAPI 04 is used in this study. A single intravenous bolus dose of 3.70-4.44 MBq/kg is administered. • Simultaneous PET/MR Acquisition: During PET imaging, cardiac MR (CMR) is performed in the supine position. All images are acquired with ECG gating and respiratory gating, during end expiratory breath holds. 1. Cardiac Morphology and Function (Localization \& Cine):Assess cardiac structure and global/regional function 2. T2 Weighted Fat Suppressed Imaging:Evaluate myocardial edema

Primary outcome measures

  • Myocardial fibrosis burden measured by 18F-FAPI PET/MR [Time frame: At baseline (within 1 week of enrollment)]
  • Myocardial fibrosis burden measured by 18F-FAPI PET/MR [Time frame: At baseline (within 1 week of enrollment)]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 80 years, regardless of sex.
  • Clinically diagnosed with chronic kidney disease (CKD), based on KDIGO guidelines.
  • Complete clinical data available.
  • Written informed consent for participation and for undergoing 18F-FAPI PET/MR imaging is obtained from the patient or their legal guardian.
  • Female participants must agree to use effective contraception during the study and for at least 6 months after its completion (e.g., sterilization, intrauterine hormonal devices, condoms, hormonal contraceptives, abstinence, or vasectomized partner). Male participants must also agree to use contraception during the study and for 6 months after its completion.

Exclusion criteria

  • Women who are planning to conceive, currently pregnant, or breastfeeding.
  • Contraindications to PET/MR imaging, including but not limited to metal implants, claustrophobia, or inability to tolerate cardiac MRI due to respiratory difficulties.
  • History of allergy or hypersensitivity to gadolinium-based contrast agents.
  • Presence of malignant tumors or other serious progressive diseases.
  • Patients with severe cardiac conditions, such as advanced heart failure, severe valvular disease, or cardiomyopathies.
  • Hemodynamic instability.
  • Presence of severe systemic or localized infections, or other serious comorbid conditions.
  • Incomplete clinical data.
  • Any other reason deemed by the investigators to make the subject unsuitable for participation, including inability or unwillingness to comply with study procedures and requirements.
  • Determined by the investigators to be inappropriate for inclusion in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Affiliated Hospital of Qingdao University — Qingdao

Identifiers

NCT: NCT07107919 · QYFYEC2025-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗