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

NCT ID: NCT05752097

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-11-30

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

[18F]AlF-NOTA-FAPI-04 PET/CT examination

Intervention Type: DEVICE

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.

Renal puncture biopsy

Intervention Type: PROCEDURE

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.

Interventions

[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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Wang, Principal Investigator

Role: CONTACT

18810566155@163.com

+8618313820216

Facility Contacts

Wei Zhang, doctor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 33829416 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34988624 (View on PubMed)

Other Identifiers

SCPHNM

Identifier Type: -

Identifier Source: org_study_id