[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

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.

Study Overview

• Status: Recruiting
• Conditions: 18F-FAPI PET/CT Examination; Renal Puncture Biopsy
• Intervention / Treatment: Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination; Procedure: Renal puncture biopsy

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Hao Wang, Principal Investigator; Phone Number: +8618313820216; Email: 18810566155@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Wei Zhang, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with first clinical diagnosis of nephritis or renal fibrosis.

Description

Inclusion Criteria:

• The pitients of nephritis or fibrosis disease

Exclusion Criteria:

• Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
• Renal biopsy cannot be performed for severe exclotting disease
• Complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor
• Unable to cooperate with renal puncture biopsy due to language communication or other problems
• Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
• Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
• Alcohol allergy
• Patients with significant decrease in urine volume due to disease
• Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved protocol
• Other circumstances deemed inappropriate by the investigator for participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Renal inflammatory or fibrotic disease; [18F]AIF-NOTA-FAPI-04 (4.81MBq/Kg) will be injected intravenously according to the patient's body weight. PET/CT examination will be performed 50-60 minutes after the injection of radiotracer. The patients will undergo renal puncture biopsy one day after PET/CT examination.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized uptake value	The extent of renal uptake of FAPI	30minutes after PET/CT examination

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital

Publications and helpful links

General Publications

• Zhou Y, Yang X, Liu H, Luo W, Liu H, Lv T, Wang J, Qin J, Ou S, Chen Y. Value of [68Ga]Ga-FAPI-04 imaging in the diagnosis of renal fibrosis. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3493-3501. doi: 10.1007/s00259-021-05343-x. Epub 2021 Apr 7.
• Conen P, Pennetta F, Dendl K, Hertel F, Vogg A, Haberkorn U, Giesel FL, Mottaghy FM. [68 Ga]Ga-FAPI uptake correlates with the state of chronic kidney disease. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3365-3372. doi: 10.1007/s00259-021-05660-1. Epub 2022 Jan 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: SCPHNM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No