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

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.

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Key information

Conditions

Chronic Kidney Disease 18F-FAPI Cardiac Magnetic Resonance Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F PET/MR

Other

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.

Cardiac Morphology and Function (Localization & Cine):Assess cardiac structure and global/regional function
T2 Weighted Fat Suppressed Imaging:Evaluate myocardial edema
First Pass Perfusion Imaging:Quantitatively assess the extent and severity of myocardial perfusion defects
Late Gadolinium Enhancement (LGE): Detect and quantify myocardial necrosis and fibrosis
T1 Mapping (Pre and Post Contrast): Quantify myocardial interstitial fibrosis
T2 Mapping (Pre Contrast):Quantify myocardial edema
Cardiac PET Imaging:Evaluate myocardial fibrosis characteristics using ^18F FAPI PET data

Primary outcomes

Myocardial fibrosis burden measured by 18F-FAPI PET/MR

Time frame: 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

Time frame: At baseline (within 1 week of enrollment)

Native T1 value, ECV, and LGE assessed by cardiac MRI to evaluate myocardial fibrosis

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Aug 6, 2025
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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