About this trial
The CT-IPF ANTHEM study is designed to prospectively compare PCDCT to HRCT scan in the identification of specific ILD diagnosis discussed during the multidisciplinary discussion to increase diagnostic confidence and reduce unclassifiable ILD cases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Any gender
Any race
Signed informed consent
Disqualifiers
Patients with acute exacerbation of ILD
Interstitial abnormalities that could be explained by causes different than ILD (e.g.: heart failure; viral)
Trial population
Adults patients with a new diagnosis of ILD referred to the outpatient clinic of ILD of Humanitas Research Hospital, Rozzano - Milano) and with the need of a MDD discussion to reach a diagnosis will be enrolled. MDD will be leaded by two pulmonologists with 5 years of experience in ILDs. Each MDD session will include at least one additional pulmonologist, two thoracic radiologists, one thoracic surgeon, one thoracic pathologist, one rheumatologist, and at least two fellows in respiratory medicine. MDD meetings will be held every week and lasted approximately 60 minutes. Patients will be discussed using a standard case report form. Two diagnosis will be collected: the first diagnosis will be collected using the HRCT scan imaging. The second diagnosis will be collected using the PCDCT scan imaging.
Trial design
Cohort
Prospective
Treatments tested in this trial
Photon counting CT
Diagnostic testNon-contrast enhanced CT will be acquired in spectral ultra-high-resolution mode on a clinical dual-source photon-counting detector CT (PCDCT) (NAEOTOM Alpha, Siemens Healthineers AG, Forchheim, Germany). All scans will be acquired with automated exposure control.
Treatment groups
Trial outcomes
Primary outcomes
Reduction of unclassifiable ILD diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Secondary outcomes
Increase in IPF diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Interobserver agreement among radiologists using Cohen's kappa
Sponsors and contacts
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