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Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05845151
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga-FAPI-04 PET
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LN Patients group

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

Outcome Measures

Primary Outcome Measures

  1. Renal FAP expression level [Baseline]

    Quantitative assessment of renal fibroblast activation on FAPI PET image

  2. Renal FAP expression level [6 months after baseline]

    Quantitative assessment of renal fibroblast activation on FAPI PET image

  3. Renal FAP expression level [12 months after baseline]

    Quantitative assessment of renal fibroblast activation on FAPI PET image

  4. Renal FAP expression level [24 months after baseline]

    Quantitative assessment of renal fibroblast activation on FAPI PET image

Secondary Outcome Measures

  1. Renal fibrosis score [Baseline]

    It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome.

  2. Chronic activity score [Baseline]

    It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

  • Principal Investigator: Hui Shi, Dr., Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT05845151
Other Study ID Numbers:
  • (2021)CER(87)
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nephritis
Lupus Nephritis

Study Results

No Results Posted as of May 6, 2023