Iodine Mapping Using Subtraction in Pulmonary Embolism CT Versus Dual-Energy CT (InSPECT-DECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02890706|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Device: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography||Not Applicable|
Rationale: Iodine mapping of the lung using subtraction imaging in addition to standard computed tomography pulmonary angiography (CTPA) may improve the evaluation of pulmonary embolism (PE) in the same manner as the addition of dual energy computed tomography (DECT) to CTPA.
Objective: To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that subtracts a low radiation dose unenhanced CT from mono-energetic CTPA (subtraction) Study design: A maximum of 375 patients will undergo a standard CTPA with DECT according to local clinical guidelines, to have 30 patients with pulmonary embolism. For the purposes of this study, patients will undergo an additional unenhanced, low-radiation dose chest CT. Standard reconstructions of all scans and DECT iodine maps will be obtained for clinical reporting and subsequent treatment decisions, according to standard clinical routine. For research purposes, selected mono-energetic images will be post-processed using a novel subtraction algorithm to create iodine maps of the lungs. The iodine maps based on the subtraction algorithm will not be used for clinical management, only the additional unenhanced scan will be used in clinical management.
Study population: Patients presenting with a clinical indication for pulmonary CT angiography because of suspected pulmonary embolism. Only adult patients (≥ 35 years) who are able to provide informed consent will be enrolled.
Main study parameters/endpoints:
Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements.
Images will be evaluated for objective and subjective image quality. Patient characteristics, radiation dose, clinical diagnosis, treatment decisions and patient outcome (all cause - and PE related mortality) will be recorded.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
CT imaging is associated with risks related to the use of radiation and iodinated contrast administration. No additional contrast will be used as compared to standard clinical practice as patients will only undergo one CTPA scan. The CT protocol of this study has been carefully designed to have a radiation dose identical or even lower than standard CT protocols for pulmonary embolism detection. The estimated dose-length product (DLP) of standard CTPA with DECT in Meander Medical Centre is 167 mGy-cm (effective dose is 2.4 mSv, using 0,0146 mSv/mGy-cm as a conversion factor). The researchers will expose patients who participate in the study to an estimated additional DLP of 72 mGy-cm due to the unenhanced scan, resulting in an additional estimated effective dose of 1,0 mSv. This implies that the total radiation dose is within the same range as radiation doses of other scans for PE detection in the Netherlands. The additional scan is not obligatory in pulmonary embolism diagnosis, but will be used for clinical evaluation of these patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||295 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iodine Mapping Using Subtraction in Pulmonary Embolism Computed Tomography Versus Dual Energy Computed Tomography|
|Actual Study Start Date :||July 7, 2016|
|Actual Primary Completion Date :||October 30, 2017|
|Actual Study Completion Date :||October 30, 2017|
Each patient undergo the same CT protocol. Theobservers will observe the detection of the perfusion defects in two different techniques.
Device: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography
Compare two techniques of the CT scanner
- Presence of perfusion defects as reference standard [ Time Frame: 1.5 year ]After 1.5 year, the radiologists scores the presence of perfusion defects caused by pulmonary embolism as a reference standard.
- Radiation dose [ Time Frame: Through study completion, an average of 2 months ]
- Clinical diagnosis of Pulmonary embolism: after 6 months follow-up [ Time Frame: Through study completion, after the first inclusion, the patients are followed for half a year. ]
- 30-day all cause mortality and PE-associated mortality [ Time Frame: Through study completion, an average of three months ]
- 6 months all cause mortality and PE-associated mortality [ Time Frame: Through study completion, an average of three months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890706
|Nijmegen, Gelderland, Netherlands, 6500|
|Study Chair:||Monique Brink, MD||Radboud University|