Evaluation of Kidney Fibrosis Via FAPI PET/CT
ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Histological workup of native kidney present
Disqualifiers
Age <18
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
PET/CT scan
Diagnostic testIncluded patients will undergo one PET/CT scan with 68GA-FAPI tracer application
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: FAPI PET/CT scanOther 1 intervention
Trial outcomes
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov