Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

May 4, 2023 updated by: Ruijin Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal FAP expression level
Time Frame: Baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Baseline
Renal FAP expression level
Time Frame: 6 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
6 months after baseline
Renal FAP expression level
Time Frame: 12 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
12 months after baseline
Renal FAP expression level
Time Frame: 24 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
24 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal fibrosis score
Time Frame: Baseline
It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome.
Baseline
Chronic activity score
Time Frame: Baseline
It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2021)CER(87)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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