Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845151
• Other study ID #: (2021)CER(87)
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Ruijin Hospital
• Contact: Hui Shi, Dr.
• Phone: 0086 21 64370045
• Email: shihui_sjtu[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Diagnostic Test:
• 68Ga-FAPI-04 PET
Activation of renal fibroblast is quantified using 68Ga-FAPI-04 PET in patients with LN.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal FAP expression level	Quantitative assessment of renal fibroblast activation on FAPI PET image	Baseline
Primary	Renal FAP expression level	Quantitative assessment of renal fibroblast activation on FAPI PET image	6 months after baseline
Primary	Renal FAP expression level	Quantitative assessment of renal fibroblast activation on FAPI PET image	12 months after baseline
Primary	Renal FAP expression level	Quantitative assessment of renal fibroblast activation on FAPI PET image	24 months after baseline
Secondary	Renal fibrosis score	It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome.	Baseline
Secondary	Chronic activity score	It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome.	Baseline