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

NCT06563765 | Enrolling By Invitation

• 1 other identifier: 2022-386
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

CKD; Renal fibrosis; FAP

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Follow-up serum creatinine (μmol/L)

  From 1 month after enrollment to 60 month after enrollment

• Proteinuria remisssion

  From 1 month after enrollment to 60 month after enrollment

• Acute kidney disease remission

  Within 3 month after enrollment

Study Arms (1)

FAP-targeting PET/CT imaging

EXPERIMENTAL

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.

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating patients

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: August 21, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 10, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-07

Locations

CN (1)