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NCT Number: NCT07712679

Evaluation of Kidney Fibrosis Via FAPI PET/CT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General hospital Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Constantin N Aschauer, MD

CONTACT

[email protected]

004314040043910

About this study

Background More than 10% of the general population worldwide is affected by chronic kidney disease (CKD) and approximately four million people are living on renal replacement therapy. Main causes for CKD are life style factors as hypertension and diabetes. Modern therapies improve outcome and reduce disease progression and can sustain organ function by reducing fibrosis as disease progression is mostly characterized by progressive tissue remodeling, especially including fibrosis leading to GFR reduction. To quantify the degree of fibrosis an invasive procedure as the kidney biopsy is necessary.The procedure and preparation for native kidney and graft biopsies requires detailed planning as bleeding risk and consecutive consequences of bleeding potentially leading to nephrectomy have to be minimized. Nevertheless, significant complications as erythrocyte transfusions are observed in up to 1,6 % and in 0,3% invasive interventions are needed to stop bleeding following kidney biopsies. These complications occur despite optimal preparation and in significant cases a biopsy is not feasible due to vital platelet inhibition and anticoagulation or these have to be paused for several days prior to biopsy reflecting a significant time loss.

Additionally in patients with a long known CKD and comorbidities (exg. hypertension, hyperglycemia) where a rapid decrease in kidney function also with concomitant significant proteinuria can reflect the natural slope of kidney function decline and histologic biopsy work up eventually often reveals chronic lesions and extended fibrosis as cause for progressive decline in kidney function.

In these cases and due to the mentioned difficulties and significant periprocedural risk, a non-invasive tool to bona fide visualize ongoing processes or existing damage in the kidney is preferable and due to advances in imaging techniques a promising approach.

PET Imaging 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.

Nowadays widely used FDG PET/CT has proven its use in clinical practice in detecting areas of high metabolism as inflammation or cancer. By the use of alternative radiopharmaceuticals, further processes like blood flow, cell proliferation or receptor distribution in organs can be quantified at the molecular level. Fibrosis evaluation using 68Ga-FAPI tracer demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut and small studies have already shown promising results in fibrosis evaluation in native kidneys.

Methods We aim to prospectively include 30 patients with different degrees of fibrosis in the kidney biopsy and perform a PET/CT scan using 68Ga-DOTA.SA.FAPi tracer to evaluate a correlation between tracer uptake and the histologic findings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological workup of native kidney present

Exclusion criteria

  • Age <18
  • Pregnancy

Treatment and study plan

PET/CT scan

Diagnostic Test

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

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.

    Time frame: 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Constantin N Aschauer, MD

CONTACT

[email protected]

004314040043910

Rainer Oberbauer, MD, PhD, MD, PhD

CONTACT

[email protected]

004314040043900

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Evaluation of Renal Renal Fibrosis Vie FAPI-PET-CT: a Prospective Non-randomized Open-label Single-center Pilot Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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