Heart imaging with 18F-FAPI PET/MR in people with different stages of chronic kidney disease

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

We will use 18F-FAPI PET/MR scans to see if heart function and myocardial fibrosis differ between people with mild versus advanced chronic kidney disease.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT07107919 on ClinicalTrials.gov

What this trial studies

This is a prospective cohort enrolling consecutive eligible adults with chronic kidney disease who will undergo combined 18F-FAPI PET and cardiac MRI. Participants are stratified into two groups by eGFR: stages 1–3 (eGFR ≥ 30 mL/min/1.73 m²) and stages 4–5 (eGFR < 30 mL/min/1.73 m²). The imaging protocol measures global cardiac function and maps myocardial fibroblast activity and fibrosis signals. Investigators will analyze the relationships between imaging biomarkers and the degree of renal dysfunction using clinical and laboratory data.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with a clinical diagnosis of CKD who can tolerate PET/MR imaging and provide informed consent.

Not a fit: Patients who are pregnant, breastfeeding, planning to conceive, or who have MRI/PET contraindications (e.g., certain metal implants, severe claustrophobia, or inability to lie flat) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could reveal early cardiac fibrosis in CKD patients and help guide timing of heart-protecting interventions.

How similar studies have performed: Early clinical studies using 18F-FAPI have shown promise for detecting myocardial fibrosis in cardiac disease, but applying it across CKD stages is relatively novel.

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.

Where this trial is running

Qingdao, Shandong

• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Pei Nie — The Affiliated Hospital of Qingdao University
• Study coordinator: Pei Nie, MD

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