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CT staging and monitoring of fibrotic interstitial lung diseases in clinical practice and treatment trials: a Position Paper from the Fleischner society

CT staging and monitoring of fibrotic interstitial lung diseases in clinical practice and treatment trials: a Position Paper from the Fleischner society
CT staging and monitoring of fibrotic interstitial lung diseases in clinical practice and treatment trials: a Position Paper from the Fleischner society

CT is increasingly being used to stage and quantify the extent of diffuse lung diseases both in clinical practice and in treatment trials. The role of CT in the assessment of patients entering treatment trials has greatly expanded as clinical researchers and pharmaceutical companies have focused their efforts on developing safe and effective drugs for interstitial lung diseases, particularly for idiopathic pulmonary fibrosis. These efforts have culminated in the simultaneous approval by the US Food and Drug Administration of two new drugs for the treatment of idiopathic pulmonary fibrosis. CT features are a key part of the inclusion criteria in many drug trials and CT is now being used to refine the type of patients enrolled. Interest in the potential use of serial CT as an effectiveness endpoint is increasing. For chronic progressive diseases, mortality may not be a feasible endpoint and many surrogate markers have been explored, ranging from pulmonary function decline to biomarkers. However, these surrogate markers are not entirely reliable and combinations of endpoints, including change in disease extent on CT, are being investigated. Methods to assess disease severity with CT range from simple visual estimates to sophisticated quantification by use of software. In this Position Paper, which cannot be regarded as a comprehensive set of guidelines in view of present knowledge, we examine the uses of serial CT in clinical practice and in drug trials and draw attention to uncertainties and challenges for future research.

2213-2600
483-496
Hansell, David M.
6ffd4a69-9a48-4062-b0ca-c509faedede7
Goldin, Jonathan G.
86a0b8fc-7491-41cc-be1a-bda1c4f5ec72
King, Talmadge E.
4514ccf1-980f-4216-bfe9-26f6f3c96638
Lynch, David A.
25c32c88-aa32-4e2e-97ae-bc1445bc8d98
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Wells, Athol U.
47bba0f1-7cf9-4e3d-97b3-2be719a87357
Hansell, David M.
6ffd4a69-9a48-4062-b0ca-c509faedede7
Goldin, Jonathan G.
86a0b8fc-7491-41cc-be1a-bda1c4f5ec72
King, Talmadge E.
4514ccf1-980f-4216-bfe9-26f6f3c96638
Lynch, David A.
25c32c88-aa32-4e2e-97ae-bc1445bc8d98
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Wells, Athol U.
47bba0f1-7cf9-4e3d-97b3-2be719a87357

Hansell, David M., Goldin, Jonathan G., King, Talmadge E., Lynch, David A., Richeldi, Luca and Wells, Athol U. (2015) CT staging and monitoring of fibrotic interstitial lung diseases in clinical practice and treatment trials: a Position Paper from the Fleischner society. The Lancet Respiratory Medicine, 3 (6), 483-496. (doi:10.1016/S2213-2600(15)00096-X).

Record type: Review

Abstract

CT is increasingly being used to stage and quantify the extent of diffuse lung diseases both in clinical practice and in treatment trials. The role of CT in the assessment of patients entering treatment trials has greatly expanded as clinical researchers and pharmaceutical companies have focused their efforts on developing safe and effective drugs for interstitial lung diseases, particularly for idiopathic pulmonary fibrosis. These efforts have culminated in the simultaneous approval by the US Food and Drug Administration of two new drugs for the treatment of idiopathic pulmonary fibrosis. CT features are a key part of the inclusion criteria in many drug trials and CT is now being used to refine the type of patients enrolled. Interest in the potential use of serial CT as an effectiveness endpoint is increasing. For chronic progressive diseases, mortality may not be a feasible endpoint and many surrogate markers have been explored, ranging from pulmonary function decline to biomarkers. However, these surrogate markers are not entirely reliable and combinations of endpoints, including change in disease extent on CT, are being investigated. Methods to assess disease severity with CT range from simple visual estimates to sophisticated quantification by use of software. In this Position Paper, which cannot be regarded as a comprehensive set of guidelines in view of present knowledge, we examine the uses of serial CT in clinical practice and in drug trials and draw attention to uncertainties and challenges for future research.

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Published date: 11 May 2015

Identifiers

Local EPrints ID: 443445
URI: http://eprints.soton.ac.uk/id/eprint/443445
ISSN: 2213-2600
PURE UUID: 376ecbb4-1e28-4169-97eb-8a8e935bfa99

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Date deposited: 26 Aug 2020 16:33
Last modified: 17 Mar 2024 12:41

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Contributors

Author: David M. Hansell
Author: Jonathan G. Goldin
Author: Talmadge E. King
Author: David A. Lynch
Author: Luca Richeldi
Author: Athol U. Wells

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