Iodine Subtraction Mapping in the Diagnosis of Chronic Pulmonary Thromboembolic Disease

NCT03806907 | Unknown DMC

• 1 other identifier: STH20623
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. The investigators 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

INSITIGATE; Pulmonary Hypertension; Pulmonary embolism; Chronic Thromboembolism; Iodine Subtraction

Outcome Measures

Primary Outcomes (1)

• Assessment of the diagnostic performance of CT-LSIM for evaluation of pulmonary perfusion in patients with known or suspected chronic thromboembolic pulmonary hypertension (CTEPH)

  Sensitivity and specificity

  12 months

Secondary Outcomes (5)

• Diagnostic accuracy of CT-LSIM compared with single photon emission computed tomography (SPECT)

  12 months

• Diagnostic accuracy of CT-LSIM compared with CT pulmonary angiography (CTPA)

  12 months

• Diagnostic accuracy of experienced and less experienced observers

  12 months

• Number of alternate diagnoses made on CT-LSIM over lung SPECT imaging

  12 months

• Radiation dose between CT-LSIM, SPECT and CTPA

  12 months

Interventions

Computed tomography lung subtraction iodine mapping RADIATION

Subtraction of the non-contrast CT from the contrast-enhance CTPA produces the CT-LSIM

Also known as: CT-LSIM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient suspected to have or diagnosed with chronic thromboembolic disease and require a SPECT and CTPA

You may qualify if:

• Patients suspected to have CTED and require a SPECT and CTPA

You may not qualify if:

• Less than 18 years old
• Unable to provide informed consent
• Significant renal dysfunction (GFR \<30ml/min)
• History of hypersensitivity to contrast material
• Pregnancy

Sponsors & Collaborators

• University of Sheffield: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Related Publications (6)

• Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274.

  PMID: 15163775 BACKGROUND

• Hoey ET, Gopalan D, Ganesh V, Agrawal SK, Qureshi N, Tasker AD, Clements L, Screaton NJ. Dual-energy CT pulmonary angiography: a novel technique for assessing acute and chronic pulmonary thromboembolism. Clin Radiol. 2009 Apr;64(4):414-9. doi: 10.1016/j.crad.2008.11.007. Epub 2009 Jan 14. No abstract available.

  PMID: 19264187 BACKGROUND

• Hoey ET, Mirsadraee S, Pepke-Zaba J, Jenkins DP, Gopalan D, Screaton NJ. Dual-energy CT angiography for assessment of regional pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension: initial experience. AJR Am J Roentgenol. 2011 Mar;196(3):524-32. doi: 10.2214/AJR.10.4842.

  PMID: 21343493 BACKGROUND

• Gulani V, Calamante F, Shellock FG, Kanal E, Reeder SB; International Society for Magnetic Resonance in Medicine. Gadolinium deposition in the brain: summary of evidence and recommendations. Lancet Neurol. 2017 Jul;16(7):564-570. doi: 10.1016/S1474-4422(17)30158-8. Epub 2017 Jun 13.

  PMID: 28653648 BACKGROUND

• Rajaram S, Swift AJ, Capener D, Telfer A, Davies C, Hill C, Condliffe R, Elliot C, Hurdman J, Kiely DG, Wild JM. Diagnostic accuracy of contrast-enhanced MR angiography and unenhanced proton MR imaging compared with CT pulmonary angiography in chronic thromboembolic pulmonary hypertension. Eur Radiol. 2012 Feb;22(2):310-7. doi: 10.1007/s00330-011-2252-x. Epub 2011 Sep 2.

  PMID: 21887483 BACKGROUND

• Dong C, Zhou M, Liu D, Long X, Guo T, Kong X. Diagnostic accuracy of computed tomography for chronic thromboembolic pulmonary hypertension: a systematic review and meta-analysis. PLoS One. 2015 Apr 29;10(4):e0126985. doi: 10.1371/journal.pone.0126985. eCollection 2015.

  PMID: 25923810 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis

Study Officials

• David Kiely, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY DIRECTOR

• Yousef Shahin, MD

  University of Sheffield

  STUDY CHAIR

• Andy J Swift, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

• Kavitasagary Karunasaagarar

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Andy J Swift, PhD

CONTACT

0114 2159595; a.j.swift@sheffield.ac.uk

Yousef Shahin, MD

CONTACT

0114 2159595; y.shahin@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Wellcome Trust Clinical Fellow in Radiology and Consultant Cardiothoracic Radiologist

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 16, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 30, 2020
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share