Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

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 volunteers

Qualifiers

≥ 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Photon counting CT

    Diagnostic test

    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.

Treatment groups

156 Participants
are divided into 1 treatment group
Group A: ILD patients undergoing radiological evaluation1 intervention

Trial outcomes

Primary outcomes

1

Reduction of unclassifiable ILD diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test

Time frame
2 years

Secondary outcomes

1

Increase in IPF diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test

Time frame
2 years
2

Interobserver agreement among radiologists using Cohen's kappa

Time frame
2 years

Other outcomes

Sponsors and contacts

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