Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis (CT-IPF ANTHEM)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Francesco Amati, MD
- Número de telefone: +393282592750
- E-mail: franesco.amati@hunimed.eu
Estude backup de contato
- Nome: Lisa Usuelli, MD
- Número de telefone: +393400095239
- E-mail: lisa.usuelli@humanitas.it
Locais de estudo
-
-
Italy
-
Rozzano, Italy, Itália, 20089
- Recrutamento
- Humanitas Research Hospital
-
Contato:
- Lisa Usuelli, MD
- Número de telefone: +393400095239
- E-mail: lisa.usuelli@humanitas.it
-
Contato:
- Francesco Amati, MD
- Número de telefone: +393282592750
- E-mail: francesco.amati@hunimed.eu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Reduction of unclassifiable ILD diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Prazo: 2 years
|
2 years
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Increase in IPF diagnosis after MDD comparing PCDCT vs standard Chest HRCT scan using McNemar test
Prazo: 2 years
|
2 years
|
|
Interobserver agreement among radiologists using Cohen's kappa
Prazo: 2 years
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francesco Amati, MD, Humanitas Research Hospital IRCCS, Rozzano-Milan
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 599/24
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .