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

NCT07790614 | Recruiting

• 1 other identifier: 599/24
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

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 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.

ILD patients undergoing radiological evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Italy, 20089, Italy

RECRUITING

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: 23222877 BACKGROUND

• 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: 37071170 BACKGROUND

• Prayer F, Kienast P, Strassl A, Moser PT, Bernitzky D, Milacek C, Gyongyosi M, Kifjak D, Rohrich S, Beer L, Watzenbock ML, Milos RI, Wassipaul C, Gompelmann D, Herold CJ, Prosch H, Heidinger BH. Detection of Post-COVID-19 Lung Abnormalities: Photon-counting CT versus Same-Day Energy-integrating Detector CT. Radiology. 2023 Apr;307(1):e222087. doi: 10.1148/radiol.222087. Epub 2022 Nov 29.

  PMID: 36445225 BACKGROUND

• Raghu G, Remy-Jardin M, Richeldi L, Thomson CC, Inoue Y, Johkoh T, Kreuter M, Lynch DA, Maher TM, Martinez FJ, Molina-Molina M, Myers JL, Nicholson AG, Ryerson CJ, Strek ME, Troy LK, Wijsenbeek M, Mammen MJ, Hossain T, Bissell BD, Herman DD, Hon SM, Kheir F, Khor YH, Macrea M, Antoniou KM, Bouros D, Buendia-Roldan I, Caro F, Crestani B, Ho L, Morisset J, Olson AL, Podolanczuk A, Poletti V, Selman M, Ewing T, Jones S, Knight SL, Ghazipura M, Wilson KC. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2022 May 1;205(9):e18-e47. doi: 10.1164/rccm.202202-0399ST.

  PMID: 35486072 BACKGROUND

• Lynch DA, Sverzellati N, Travis WD, Brown KK, Colby TV, Galvin JR, Goldin JG, Hansell DM, Inoue Y, Johkoh T, Nicholson AG, Knight SL, Raoof S, Richeldi L, Ryerson CJ, Ryu JH, Wells AU. Diagnostic criteria for idiopathic pulmonary fibrosis: a Fleischner Society White Paper. Lancet Respir Med. 2018 Feb;6(2):138-153. doi: 10.1016/S2213-2600(17)30433-2. Epub 2017 Nov 15.

  PMID: 29154106 BACKGROUND

• Hambly N, Farooqi MM, Dvorkin-Gheva A, Donohoe K, Garlick K, Scallan C, Chong SG, MacIsaac S, Assayag D, Johannson KA, Fell CD, Marcoux V, Manganas H, Morisset J, Comes A, Fisher JH, Shapera S, Gershon AS, To T, Wong AW, Sadatsafavi M, Wilcox PG, Halayko AJ, Khalil N, Cox G, Richeldi L, Ryerson CJ, Kolb M. Prevalence and characteristics of progressive fibrosing interstitial lung disease in a prospective registry. Eur Respir J. 2022 Oct 6;60(4):2102571. doi: 10.1183/13993003.02571-2021. Print 2022 Oct.

  PMID: 35273032 BACKGROUND

• Guler SA, Ryerson CJ. Unclassifiable interstitial lung disease: from phenotyping to possible treatments. Curr Opin Pulm Med. 2018 Sep;24(5):461-468. doi: 10.1097/MCP.0000000000000509.

  PMID: 30004990 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary 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; lisa.usuelli@humanitas.it

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
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-04

Locations

IT (1)