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

NCT07107919 | Recruiting

• 1 other identifier: QYFYEC2025-103
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Cardiac Magnetic Resonance; 18F-FAPI

Keywords

CKD; Cardiac Magnetic Resonance; 18F-FAPI

Outcome Measures

Primary Outcomes (2)

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

  Myocardial uptake of 18F-FAPI quantified using SUVmax and SUVmean values from PET imaging.

  At baseline (within 1 week of enrollment)

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

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

  At baseline (within 1 week of enrollment)

Study Arms (2)

Group I (CKD stages 1-3)

eGFR ≥ 30 mL/min/1.73 m²

Other: 18F PET/MR

Group II (CKD stages 4-5)

eGFR \< 30 mL/min/1.73 m²

Other: 18F PET/MR

Interventions

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. 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

Group I (CKD stages 1-3); Group II (CKD stages 4-5)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 80 years with clinically diagnosed chronic kidney disease (CKD), classified according to the KDIGO guidelines. Participants will be stratified into two groups based on renal function: Group I (CKD stages 1-3, eGFR ≥ 30 mL/min/1.73 m²) and Group II (CKD stages 4-5, eGFR \< 30 mL/min/1.73 m²). Subjects will be consecutively recruited from the Department of Nephrology and Cardiology of The Affiliated Hospital of Qingdao University. Both male and female patients will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei Nie

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei Nie, MD

CONTACT

+86 0532-821592; niepei@qdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 6, 2025
• Study Start: July 30, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)