Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Renal FAP expression level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
LN Patients group
Intervention: 68Ga-FAPI-04 PET (Diagnostic Test)
Outcomes
Primary Outcomes
Renal FAP expression level
Time Frame: 24 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Time Frame: Baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Time Frame: 6 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Time Frame: 12 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Secondary Outcomes
- Renal fibrosis score(Baseline)
- Chronic activity score(Baseline)