Trials Sponsors Conditions Drugs Pricing

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

IPFIdiopathic pulmonary fibrosisInterstitial lung diseasesILDPhoton counting CTCT scanHRCTPCDCT

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (1)

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

Interventions

Photon counting CTDiagnostic 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.

ILD patients undergoing radiological evaluation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Sponsors & Collaborators

Istituto Clinico Humanitas
Otherlead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Italy, 20089, Italy

RECRUITING

Francesco Amati, MDCONTACT+393282592750 francesco.amati@hunimed.eu

Lisa Usuelli, MDCONTACT+393400095239 lisa.usuelli@humanitas.it

Related Publications (7)

Ryerson CJ, Urbania TH, Richeldi L, Mooney JJ, Lee JS, Jones KD, Elicker BM, Koth LL, King TE Jr, Wolters PJ, Collard HR. Prevalence and prognosis of unclassifiable interstitial lung disease. Eur Respir J. 2013 Sep;42(3):750-7. doi: 10.1183/09031936.00131912. Epub 2012 Dec 6.
PMID: 23222877BACKGROUND
Rajendran K, Koo CW. Photon-counting detector CT: improving interstitial lung disease classification using ultra-high resolution at a fraction of the radiation dose? Eur Radiol. 2023 Aug;33(8):5526-5527. doi: 10.1007/s00330-023-09617-w. Epub 2023 Apr 18. No abstract available.
PMID: 37071170BACKGROUND

MeSH Terms

Conditions

Lung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPulmonary Fibrosis

Study Officials

Francesco Amati, MD
Humanitas Research Hospital IRCCS, Rozzano-Milan
PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Amati, MD

CONTACT

+393282592750 franesco.amati@hunimed.eu

Lisa Usuelli, MD

CONTACT

+393400095239

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

August 27, 2026

Study Start

March 25, 2025

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

ILD patients undergoing radiological evaluation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

ILD patients undergoing radiological evaluation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations