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[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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05752097
Enrollment
30
Registered
2023-03-02
Start date
2023-02-01
Completion date
2024-11-30
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

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.

PROCEDURERenal 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.

Sponsors

Sichuan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value30minutes after PET/CT examinationThe extent of renal uptake of FAPI

Countries

China

Contacts

Primary ContactHao Wang, Principal Investigator
18810566155@163.com+8618313820216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026