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Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI-04 PET
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lupus Nephritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LN Patients group

Arm Description

Outcomes

Primary Outcome Measures

Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2023
Last Updated
May 4, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05845151
Brief Title
Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis
Official Title
Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LN Patients group
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI-04 PET
Intervention Description
Activation of renal fibroblast is quantified using 68Ga-FAPI-04 PET in patients with LN.
Primary Outcome Measure Information:
Title
Renal FAP expression level
Description
Quantitative assessment of renal fibroblast activation on FAPI PET image
Time Frame
Baseline
Title
Renal FAP expression level
Description
Quantitative assessment of renal fibroblast activation on FAPI PET image
Time Frame
6 months after baseline
Title
Renal FAP expression level
Description
Quantitative assessment of renal fibroblast activation on FAPI PET image
Time Frame
12 months after baseline
Title
Renal FAP expression level
Description
Quantitative assessment of renal fibroblast activation on FAPI PET image
Time Frame
24 months after baseline
Secondary Outcome Measure Information:
Title
Renal fibrosis score
Description
It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome.
Time Frame
Baseline
Title
Chronic activity score
Description
It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Shi, Dr.
Phone
0086 21 64370045
Email
shihui_sjtu@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Shi, Dr.
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Zhang, Dr.
Phone
0086-21-64370045
Email
zm11518@rjh.com.cn

12. IPD Sharing Statement

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Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

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