Evaluation of Kidney Fibrosis Via FAPI PET/CT

NCT07712679 | Recruiting

• 1 other identifier: 1363/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Kidney Disease

Keywords

Chronic kidney disease; PET/CT; FAPI Imaging; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Correlation of SUVmax and SUVmean with degree of fibrosis in the kidney biopsy assessed by H-score, firbotic area and intensitiy grade.

  The Spearman rank correlation coefficient will be used to quantify the associations between the renal PET parameters (SUVmean, SUVmax and SUVpeak) and the histological measures of fibrosis (H-score, fibrotic area and intensity grade). Firbotic area: the percentage of any fibrotic area of the cortical part of the entire biopsy core by visual assessment (in 10% increments); fibrotic grade: an ordinal interstitial fibrosis intensity grade by visual assessment of distension of tubules and staining intensity (0 = ab-sent/nearly absent, I = mild, II = moderate, III = severe) - the most abundant grade was chosen.H-score (0-300) derived from fibrotic area percentages and corre-sponding severity grades (0-3). Statistics will be performed with Rstudio.

  Patients are included on behalf of the kidney biopsy result and one PET/CT scan will be performed. The statistical analysis and interpretation will be performed immediately after the PET/CT scan.

Study Arms (1)

FAPI PET/CT scan

OTHER

All included patients will have a FAPI PET/CT scan

Diagnostic Test: PET/CT scan

Interventions

PET/CT scan DIAGNOSTIC_TEST

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

FAPI PET/CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological workup of native kidney present

You may not qualify if:

• Age \<18
• Pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

General hospital Vienna

Vienna, State of Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Fibrosis

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Rainer Oberbauer, MD, PhD

  Medical University of Vienna, Internal Medicine III, Department of Nephrology and Dialysis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constantin N Aschauer, MD

CONTACT

004314040043910; constantin.aschauer@muv.ac.at

Rainer Oberbauer, MD, PhD, MD, PhD

CONTACT

004314040043900; rainer.oberbauer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr.med Rainer Oberbauer PhD

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 17, 2026
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

AU (1)