Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05845151

Enrollment

Registered

2023-05-06

Start date

2021-05-01

Completion date

2024-04-30

Last updated

2023-05-06

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

Conditions

Lupus Nephritis

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.

Interventions

DIAGNOSTIC_TEST68Ga-FAPI-04 PET

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Renal FAP expression level	Baseline	Quantitative assessment of renal fibroblast activation on FAPI PET image

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactHui Shi, Dr.

shihui_sjtu@sina.com0086 21 64370045

Outcome results

None listed

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