Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Not Applicable

Recruiting

• Conditions: Lupus Nephritis
• Interventions: Diagnostic Test: 68Ga-FAPI-04 PET

• Registration Number: NCT05845151
• Lead Sponsor: Ruijin Hospital

Brief Summary

Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Be between 18-80 years old;
• Confirmed SLE: meet the 2019 EULAR/ACR classification standards;
• There are signs of renal involvement and indications for renal puncture: proteinuria> 0.5g/24 hours (or urine protein creatine ratio (UPCR) >500mg/g), unexplained decrease of glomerular filtration rate (GFR)

Exclusion Criteria

• The pathology of renal puncture is not consistent with lupus nephritis;
• Previous history of other kidney diseases;
• There are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney;
• History of malignant tumors within 5 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LN Patients group	68Ga-FAPI-04 PET	-

Primary Outcome Measures

Name	Time	Method
Renal FAP expression level	24 months after baseline	Quantitative assessment of renal fibroblast activation on FAPI PET image

Secondary Outcome Measures

Name	Time	Method
Renal fibrosis score	Baseline	It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome.
Chronic activity score	Baseline	It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China