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Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Lupus Nephritis

Treatments

Diagnostic Test: 68Ga-FAPI-04 PET

Study type

Interventional

Funder types

Other

Identifiers

NCT05845151
(2021)CER(87)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

LN Patients group
Experimental group
Treatment:
Diagnostic Test: 68Ga-FAPI-04 PET

Trial contacts and locations

1

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Central trial contact

Hui Shi, Dr.

Data sourced from clinicaltrials.gov

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