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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07790614
Acronym
CT-IPF ANTHEM
Enrollment
156
Registered
2026-08-27
Start date
2025-03-25
Completion date
2026-12-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CT, CT Photon-Counting, CT Scan, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF), ILD, Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Interstitial Lung Disease (ILD), Interstitial Lung Diseases, IPF

Keywords

IPF, Idiopathic pulmonary fibrosis, Interstitial lung diseases, ILD, Photon counting CT, CT scan, HRCT, PCDCT

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTPhoton 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.

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 18 years of age * Any gender * Any race * Signed informed consent * ILD diagnosis with the need for a multidisciplinary discussion

Exclusion criteria

* Patients with acute exacerbation of ILD * Interstitial abnormalities that could be explained by causes different than ILD (e.g.: heart failure; viral)

Design outcomes

Primary

MeasureTime frame
Reduction of unclassifiable ILD diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test2 years

Secondary

MeasureTime frame
Increase in IPF diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test2 years
Interobserver agreement among radiologists using Cohen's kappa2 years

Countries

Italy

Contacts

CONTACTFrancesco Amati, MD
franesco.amati@hunimed.eu+393282592750
CONTACTLisa Usuelli, MD
lisa.usuelli@humanitas.it+393400095239
PRINCIPAL_INVESTIGATORFrancesco Amati, MD

Humanitas Research Hospital IRCCS, Rozzano-Milan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026