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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: niepei@qdu.edu.cn
• Phone: +86 0532-821592

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.