FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis

Chronic kidney disease (CKD) is an irreversible change of kidney function and structure caused by many reasons. The main threat of CKD to human health is progressive renal function decline. Delaying the progression of chronic kidney disease to end-stage renal failure is an important clinical need, and renal fibrosis is a common pathway for the progression of chronic kidney disease to end-stage renal failure. The evaluation of renal fibrosis is of great value for the course and prognosis of patients with chronic kidney disease. However, pathological detection has the disadvantages of trauma, false negative, and cannot be implemented repeatedly. At present, there is a lack of effective non-invasive, dynamic, real-time monitoring and evaluation means. A commercially available FAP-targeted imaging agent, FAPI-04, has been used for PET/CT imaging of systemic fibrosis lesions with high uptake background in normal kidneys. Although it can show severe renal fibrosis, it is not conducive to the detection rate of patients with mild-moderate fibrosis who need more accurate evaluation. The new targeted FAP imaging agent successfully constructed by our research group has proved that it can show the degree of renal fibrosis at the living level and has correlation. Therefore, this study intends to carry out a series of clinical studies on the imaging of renal fibrosis with new targeted FAP probes, evaluate the specificity and sensitivity of the new targeted FAP probes in the diagnosis of renal fibrosis, and ultimately provide a new method for clinical dynamic, non-invasive assessment and monitoring of the degree and progression of renal fibrosis.

Study Overview

• Status: Enrolling by invitation
• Conditions: CKD; Renal Fibrosis
• Intervention / Treatment: Other: FAP-targeting PET/CT imaging will be performed on the enrolled patients.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with chronic kidney disease
• Renal pathology was performed within 2 weeks

Exclusion Criteria:

• Pregnant or lactating patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAP-targeting PET/CT imaging; FAP-targeting PET/CT imaging will be performed on the enrolled patients.	Other: FAP-targeting PET/CT imaging will be performed on the enrolled patients.; FAP-targeting PET/CT imaging will be performed on the enrolled patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological type	pathological type (e.g., sclerosing IgA nephropathy)	1 week after enrollment
Baseline serum creatinine (μmol/L)	laboratory results	1 month before enrollment and 1 month after enrollment
Baseline 24-hour urinary protein (g/24h)	laboratory results	1 month before enrollment and 1 month after enrollment
Quantified renal pathological involvement.	Based on kidney biopsy sections, interstitial atrophy, interstitial inflammatory infiltration, and tubular fibrosis will be quantified.	1 week after enrollment
Pathological MESTC score	MESTC score (0-2, for IgA nephropathy patients)	1 week after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up serum creatinine (μmol/L)	laboratory results	From 1 month after enrollment to 60 month after enrollment
Proteinuria remisssion	For IgA nephropathy (IgAN) patients with baseline urinary total protein (UTP) exceeding 0.5 g/24h, a reduction of UTP to below 0.5 g/24h without recurrence within 4 weeks was considered proteinuria remission.	From 1 month after enrollment to 60 month after enrollment
Acute kidney disease remission	For IgAN patients with AKD, AKD remission was defined as a reduction in SCr to below 75% of the peak value within 90 days after imaging. Remission was classified as complete if the difference between the last recorded SCr and baseline SCr was ≤26.5 μmol/L; otherwise, it was classified as partial. Baseline SCr was defined as the lowest value recorded within 90 days prior to hospital admission. If unavailable, the lowest SCr value within 90 days after admission was used as the baseline.	Within 3 month after enrollment

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: June 2, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CKD; FAP; Renal fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 2022-386

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No