Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

NCT ID: NCT05845151

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lupus Nephritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LN Patients group

Group Type EXPERIMENTAL

68Ga-FAPI-04 PET

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-FAPI-04 PET

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hui Shi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ruijin Hospital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hui Shi, Dr.

Role: CONTACT

0086 21 64370045

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Min Zhang, Dr.

Role: primary

0086-21-64370045

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

(2021)CER(87)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of Telitacicept in Lupus Nephritis
NCT05680480 RECRUITING PHASE2