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

NCT ID: NCT06563765

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2027-05-10

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.

Conditions

CKD; Renal Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FAP-targeting PET/CT imaging

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant or lactating patients

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

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2022-386

Identifier Type: -

Identifier Source: org_study_id