interventional
N/A
1 country
1
To evaluate whether baseline pulmonary FAPI uptake on PET/CT differs between subsequent responders and non-responders to a clinically indicated modification of anti-inflammatory therapy in patients with fibrotic ILD, and to estimate the magnitude and uncertainty of this difference.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2024
Actual (reported)The difference in baseline wlTL-FAPI between participants classified as responders and non-responders at six months
The correlation between baseline wlTL-FAPI and the continuous absolute change in FVC% predicted from baseline to six months
The prognostic classification performance of baseline wlTL-FAPI, assessed using the area under the receiver operating characteristic curve and estimates of sensitivity, specificity, positive predictive value and negative predictive value, with 95% confidence intervals
Data-derived candidate wlTL-FAPI threshold(s) and their corresponding sensitivity, specificity, positive predictive value and negative predictive value
Between-group differences and associations for qualitative visual assessment, SUVmax, SUVmean, metabolic active volume and whole-lung metabolic active volume
The association between baseline wlTL-FAPI and the extent of fibrotic ILD and degree of reticulation on baseline HRCT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
Andor van den Hoven
First Submitted
July 24, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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