Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis (CT-IPF ANTHEM)

August 25, 2026 updated by: Istituto Clinico Humanitas
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ILD patients undergoing radiological evaluation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of unclassifiable ILD diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in IPF diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Time Frame: 2 years
2 years
Interobserver agreement among radiologists using Cohen's kappa
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Francesco Amati, MD, Humanitas Research Hospital IRCCS, Rozzano-Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 599/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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