IodiNe Subtraction mapping in the diagnosis of Pulmonary chronIc thRomboEmbolic disease (INSPIRE): Rationale and methodology of a cross-sectional observational diagnostic study

Contemporary Clinical Trials Communications
Yousef ShahinAndy J Swift

Abstract

Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe but treatable disease that is commonly underdiagnosed. Computed tomography lung subtraction iodine mapping (CT-LSIM) in addition to standard CT pulmonary angiography (CTPA) may improve the evaluation of suspected chronic pulmonary embolism and improve the diagnostic pick up rate. We aim to recruit 100 patients suspected of having CTEPH and perform CT-LSIM scans in addition to the current gold standard test of nuclear medicine test (lung single photon emission computed tomography (SPECT) imaging) as a pilot study which will contribute to and inform the definitive trial. The diagnostic accuracy of CT-LSIM and lung SPECT will be compared. The primary outcome of the full definitive study is non-inferiority of CT-LSIM versus lung SPECT imaging.

References

May 28, 2004·The New England Journal of Medicine·Vittorio PengoUNKNOWN Thromboembolic Pulmonary Hypertension Study Group
Sep 9, 2008·European Journal of Radiology·Sven F ThiemeThorsten R C Johnson
Apr 1, 2009·Seminars in Nuclear Medicine·Paul J RoachBenjamin E Harris
Dec 28, 2010·European Journal of Radiology·S F ThiemeT R C Johnson
Nov 8, 2012·Circulation. Cardiovascular Interventions·Masaharu KataokaToru Satoh
Jun 28, 2017·Lancet Neurology·Vikas GulaniUNKNOWN International Society for Magnetic Resonance in Medicine
Jul 14, 2018·The European Respiratory Journal·Syed Rehan QuaderyDavid G Kiely

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Citations

Nov 21, 2020·The Lancet. Respiratory Medicine·Ranju T DhawanOnn M Kon

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Clinical Trials Mentioned

NCT03806907

Software Mentioned

LSIM
OsiriX
CT
Aquilion ONE / Vision Edition ( SURESubtraction Lung
INSPIRE
Statistical Package for the Social Sciences Program ( SPSS )

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