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

NCT ID: NCT07107919

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-06-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I (CKD stages 1-3)

eGFR ≥ 30 mL/min/1.73 m²

18F PET/MR

Intervention Type: 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 II (CKD stages 4-5)

eGFR \< 30 mL/min/1.73 m²

18F PET/MR

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei Nie

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pei Nie, MD

Role: CONTACT

niepei@qdu.edu.cn

+86 0532-821592

Facility Contacts

Pei Nie, MD

Role: primary

niepei@qdu.edu.cn

Other Identifiers

QYFYEC2025-103

Identifier Type: -

Identifier Source: org_study_id