Chronic Kidney DiseaseCardiac Magnetic Resonance18F-FAPI
Investigational drug(s) / intervention(s)
18F PET/MR
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
3. First Pass Perfusion Imaging:Quantitatively assess the extent and severity of myocardial perfusion defects
4. Late Gadolinium Enhancement (LGE): Detect and quantify myocardial necrosis and fibrosis
5. T1 Mapping (Pre and Post Contrast): Quantify myocardial interstitial fibrosis
6. T2 Mapping (Pre Contrast):Quantify myocardial edema
7. Cardiac PET Imaging:Evaluate myocardial fibrosis characteristics using \^18F FAPI PET data
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 80 years, regardless of sex.
2. Clinically diagnosed with chronic kidney disease (CKD), based on KDIGO guidelines.
3. Complete clinical data available.
4. Written informed consent for participation and for undergoing 18F-FAPI PET/MR imaging is obtained from the patient or their legal guardian.
5. 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:
1. Women who are planning to conceive, currently pregnant, or breastfeeding.
2. Contraindications to PET/MR imaging, including but not limited to metal implants, claustrophobia, or inability to tolerate cardiac MRI due to respiratory difficulties.
3. History of allergy or hypersensitivity to gadolinium-based contrast agents.
4. Presence of malignant tumors or other serious progressive diseases.
5. Patients with severe cardiac conditions, such as advanced heart failure, severe valvular disease, or cardiomyopathies.
6. Hemodynamic instability.
7. Presence of severe systemic or localized infections, or other serious comorbid conditions.
8. Incomplete clinical data.
9. 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.
10. Determined by the investigators to be inappropriate for inclusion in the study.
Primary outcome measure(s)
Myocardial fibrosis burden measured by 18F-FAPI PET/MR — At baseline (within 1 week of enrollment) Myocardial uptake of 18F-FAPI quantified using SUVmax and SUVmean values from PET imaging.
Myocardial fibrosis burden measured by 18F-FAPI PET/MR — At baseline (within 1 week of enrollment) Native T1 value, ECV, and LGE assessed by cardiac MRI to evaluate myocardial fibrosis
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
More The Affiliated Hospital of Qingdao University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.