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NCT Number: NCT07790614

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Amati, MD

CONTACT

[email protected]

+393282592750

Lisa Usuelli, MD

CONTACT

[email protected]

+393400095239

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: CT-IPF ANTHEM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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