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Iodine Subtraction Mapping in the Diagnosis of Chronic Pulmonary Thromboembolic Disease

NCT03806907 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-02-12

No results posted yet for this study

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

Interventions

RADIATION

Computed tomography lung subtraction iodine mapping

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

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    collaborator OTHER

  • University of Sheffield

    lead OTHER

Principal Investigators

  • David Kiely, MD · Sheffield Teaching Hospitals NHS Foundation Trust

  • Yousef Shahin, MD · University of Sheffield

  • Andy J Swift, PhD · University of Sheffield

  • Kavitasagary Karunasaagarar · Sheffield Teaching Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-04-01
Completion
2020-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806907 on ClinicalTrials.gov