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Evaluation of Kidney Fibrosis Via FAPI PET/CT

NCT07712679 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-17

No results posted yet for this study

Summary

Interstitial fibrosis is a hallmark of progression in chronic kidney disease (CKD), yet it can presently be assessed only by kidney biopsy, which is invasive and prone to sampling error.

In recent years the advances in molecular imaging, especially high spatial and temporal resolution of the scanners and the development of radiopharmaceuticals to visualize metabolic processes or immune cells have been significant, opening promising possibilities in multiple fields. It was demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers, as 68Ga-FAPI tracer in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut. Also first data in small studies including patients with chronic kidney disease showed promising results indicating that tracer uptake could reflect the degree of fibrosis.

This study aims to investigate the utility of PET/CT imaging with a \[68Ga\]-DOTA.SA.FAPi tracer to reflect the degree of fibrosis found in the histological work up. We hypothesize that PET/CT findings reflect histological found fibrotic changes in kidney biopsies, potentially offering a superior alternative due to its non-invasive nature and the possibility to capture the entire organ.

Conditions

Interventions

DIAGNOSTIC_TEST

PET/CT scan

Included patients will undergo one PET/CT scan with 68GA-FAPI tracer application

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Rainer Oberbauer, MD, PhD · Medical University of Vienna, Internal Medicine III, Department of Nephrology and Dialysis

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712679 on ClinicalTrials.gov