Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

NCT05845151 | Unknown

• 1 other identifier: (2021)CER(87)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (4)

• Renal FAP expression level

  Quantitative assessment of renal fibroblast activation on FAPI PET image

  Baseline

• Renal FAP expression level

  Quantitative assessment of renal fibroblast activation on FAPI PET image

  6 months after baseline

• Renal FAP expression level

  Quantitative assessment of renal fibroblast activation on FAPI PET image

  12 months after baseline

• Renal FAP expression level

  Quantitative assessment of renal fibroblast activation on FAPI PET image

  24 months after baseline

Secondary Outcomes (2)

• Renal fibrosis score

  Baseline

• Chronic activity score

  Baseline

Study Arms (1)

LN Patients group

EXPERIMENTAL

Diagnostic Test: 68Ga-FAPI-04 PET

Interventions

68Ga-FAPI-04 PET DIAGNOSTIC_TEST

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

LN Patients group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hui Shi, Dr.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Shi, Dr.

CONTACT

0086 21 64370045; shihui_sjtu@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

CN (1)