NCT05752097

[18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases

Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. The main questions it aims to answer are: * Can 18F-FAPI PET/CT accurately evaluate the inflammation and fibrosis of kidney disease? * What is the value of 18F-FAPI PET/CT as a non-invasive assessment of inflammation and fibrosis in kidney disease? Participants will receive \[18F\]AlF-NOTA-FAPI-04 PET/CT and renal aspiration biopsy.

Conditions

• 18F-FAPI PET/CT Examination
• Renal Puncture Biopsy

Interventions

Type	Name	Description
DEVICE	[18F]AlF-NOTA-FAPI-04 PET/CT examination	The intravenous radiotracer dose is 1.85-2.59 MBq/kg, and imaging will be performed 50-60 min after radiotracer injection. All patients are required to urinate as much as possible for imaging preparations, which reduces the influence of the residual radiotracer in the renal pelvis and calyces. Some patients with poor renal function (GFR\<60 mL/min, urine volume \< 1000 mL/24 h) will be given diuretics (Furosemide, 0.57 mg/kg). The scope of the whole-body inspection is from the base of the skull to the base of the thigh, using five to six beds (3 min/bed). The matrix was 128×128, the PET layer thickness was 3 mm, and all PET images are reconstructed iteratively.
PROCEDURE	Renal puncture biopsy	The patients undergo renal puncture biopsy one day after PET/CT examination. Pathological results of renal biopsy will be collected after surgery, including but not limited to: pathological diagnosis, proportion of glomerulosclerosis, extent of inflammatory cell infiltration, and degree of renal interstitial fibrosis.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-08-30
• Completion: 2024-11-30
• First posted: 2023-03-02
• Last updated: 2024-01-24

Locations

1 site across 1 country: China