INSPIRE
Research type
Research Study
Full title
IodiNe Subtraction mapping in the diagnosis of Pulmonary chronIc thRomboEmbolic disease (INSPIRE): A cross sectional observational diagnostic study
IRAS ID
258320
Contact name
Andy Swift
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Chronic thromboembolic disease (CTED) is a severe but treatable disease that is commonly underdiagnosed. The purpose of this study is to determine whether computed tomography (CT) lung subtraction iodine mapping (LSIM) and a ventilation CT is better at diagnosing CTED than the current standard of care (lung SPECT imaging and CT Pulmonary Angiogram). The new CT scans (CT-LSIM and ventilation CT) is a thorough evaluation of the lungs and circulatory system as well as surrounding tissue. This means that it has the potential to improve the accuracy of diagnosis and increase the pick-up rate of patients with lung clots across the country.
If this study shows that the new CT scans can replace lung SPECT imaging, this could mean that patients would need one less investigation. The SPECT scan requires an injection of a radioisotope then 30-40 minutes in a CT scanner to collect the images. CT-LSIM images are created by merging CTPA and non contrast chest CT images and the ventilation scan is created by combining the low dose inspiratory and expiratory unenhanced CT scans. These scans can be performed together in less than 10 minutes total scanning time. Another benefit is that the new scan is cheaper than the old scan so would potentially save £325 per patient if it is shown to be as effective.
Patients presenting with suspected CTED will be invited to take part. Participation will not require an extra hospital visit for participants and will only take a few extra minutes as the non-contrast CT scan is performed at the same time as CTPA. The CT images will be subsequently evaluated by three experts who are blinded to clinical data. Statistical analyses will be performed to determine the diagnostic accuracy of CT-LSIM compared to lung SPECT imaging.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0505
Date of REC Opinion
9 Oct 2019
REC opinion
Further Information Favourable Opinion