An observational study in IPF, ILD and Interstitial Lung Disease (ILD), sponsored by Istituto Clinico Humanitas. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Istituto Clinico Humanitas · Observational
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.
The advent of a new generation of CT systems based on photon-counting detector technology is raising great interest in the medical community, anticipating a major improvement in numerous clinical applications including chest disorders. These expectations are drawn from the technological advantages inherent to these new CT systems, including a higher contrast-to-noise ratio, higher spatial resolution, and lower radiation dose together with the potential of multienergy imaging.
Non-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.
Recent evidence showed that images obtained with PCDCT allowed a more precise depiction of CT features of ILDs with similar radiation dose. Subjective visualization of specific IPF features, such as reticulation and traction bronchiectasis, using PCDCT has been rated superior to conventional HRCT. Thus, a more precise delineation of fine fibrotic abnormalities could modify the categorization of ILD patterns and improve the diagnostic confidence of IPF and not-IPF diagnosis, reducing the prevalence of unclassifiable ILD.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 156 is close to the median of 152 across 165 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
Compared within Idiopathic Pulmonary Fibrosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Diseases, Interstitial. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible partecipants will be adults (≥ 18 years of age) 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.
Diagnostic Test: Photon counting CT
Non-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.
Reduction of unclassifiable ILD diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Time frame: 2 years
Increase in IPF diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Time frame: 2 years
Interobserver agreement among radiologists using Cohen's kappa
Time frame: 2 years
Plan to share: Undecided
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
Of 74 non-industry observational studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 110. This study's planned 21 months is below that.
Counting every sponsor, half of 88 studies reached it within 54 months; a quarter within 29 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
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Idiopathic Pulmonary Fibrosis →