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

Not Applicable

• Conditions: Renal Fibrosis; CKD
• Interventions: Other: FAP-targeting PET/CT imaging will be performed on the enrolled patients.

• Registration Number: NCT06563765
• Lead Sponsor: Peking University First Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-10
• Study First Submitted: 2024-06-02
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-05-10
• Study Completion: 2026-05-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

• Pregnant or lactating patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAP-targeting PET/CT imaging	FAP-targeting PET/CT imaging will be performed on the enrolled patients.	FAP-targeting PET/CT imaging will be performed on the enrolled patients.

Primary Outcome Measures

Name	Time	Method
24-hour urinary protein (g/24h)	1 month before enrollment and 1 month after enrollment	laboratory results
Pathological type	1 week after enrollment	pathological type (e.g., sclerosing IgA nephropathy)
Pathological MESTC score	1 week after enrollment	MESTC score (0-2)
serum creatinine (μmol/L)	1 month before enrollment and 1 month after enrollment	laboratory results

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China