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IRCT20220313054273N1 IRCT 2022-08-19 Shiraz University of Medical Sciences ٍThe effect of contrast agent reduction and low dose radiation on image quality in Pulmonary CT angiography Investigating the effect of contrast agent reduction and lowering radiation dose on the image quality of pulmonary Computed Tomography (CT) in patients suspected of pulmonary thromboembolism using iterative reconstruction 2022-08-23 anticipated 40 Complete https://irct.ir/trial/62789 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: This study will be done by simple randomization. The unit of randomization is individual. The table of random numbers that will be used in this study contains a series of numbers, zero and one, produced by the random method. In this study, the table of random numbers will be used to make the sequence random. Zero and one numbers will be allocated to the control (standard pulmonary CT Angio) and intervention (contrast agent reduction and low dose of radiation) groups, respectively. This process will continue until the end of the sampling process so that finally 20 patients will be assigned to each group, Blinding description: In this study, the investigator (radiologists who evaluate the quality of pulmonary CTA) and patients (ready to take part in this study and signed consent form) are not aware of the scanning protocol. They are blind to the amount of contrast agent and radiation dose. Technologists responsible for scanning patients and the student responsible for performing the study are aware of the scanning protocol. N/A Pulmonary thromboembolism. Intervention 1: Intervention group: Patients suspected of pulmonary embolism referred to Shahid Faghihi Hospital (Shiraz) will be scanned by contrast agent reduction and radiation dose reduction protocol. The amount of injected contrast agent to the patients in intervention group will be 0.5 millilitre per each kilogram of body weight. The Pecnograph contains 300mgI/ml (milligram iodine per millilitre) made in Iran is the available contrast agent. This contrast agent will be used to scan patients in intervention group. These patients will be scanned by 128-MDCT Philips Ingenuity system, made in Netherland, at 100kVp. This CT system uses Iterative Reconstruction (IR) algorithm to reconstruct CT images. The pulmonary CT Angio images of patients in intervention group will be reconstructed by iDose level4 (a type of IR reconstruction), made in Netherland by Philips Company. Intervention 2: Control group: Patients suspected of pulmonary embolism referred to Shahid Faghihi Hospital (Shiraz) will be scanned by standard protocol (pulmonary CT Angio). The amount of injected contrast agent to the patients in control group will be 1.0 millilitre per each kilogram of patient’s body weight. The Pecnograph contains 300mgI/ml (milligram iodine per millilitre) made in Iran is the available contrast agent. This contrast agent will be used to scan patients in control group. The patients in control group will be scanned by 128-MDCT Philips Ingenuity system, made in Netherland, at 100kVp. This CT system uses Iterative Reconstruction (IR) algorithm to reconstruct CT images. The pulmonary CT Angio images of patients in control group will be reconstructed by iDose level4 (a type of IR reconstruction), made in Netherland by Philips Company. Yes - There is a plan to make this available What will be shared: Part of the data can be shared after unidentified. When: 3 months after publication To whom: Interested researchers in this field Conditions: using for research work Where to obtain: Research and technology deputy How to obtain: Sending an Email to the research and technology deputy Shiraz University of Medical Sciences Comments:
public Rezvan Ravanfar Haghighi
Medical Imaging Research Centre, 8th Floor, Mohammad Rasolallah Research Tower, Khalili street
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1464 sravanfarr@gmail.com Shiraz University of Medical Sciences scientific Rezvan Ravanfar Haghighi
Medical Imaging Research Centre, 8th Floor, Mohammad Rasolallah Research Tower, Khalili street
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1464 sravanfarr@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients who are suspicious of pulmonary emboly on the basis of clinical indication Abnormal level of plasma D-dimer Having deep veins thrombosis of lower limb age > 18 years BMI less than 30kg/m2 GFR greater than 60ml/min/1.73m2 Creatinine less than 1.3mg/ml Willingness to participate in the study and sign informed consent Does not have allergy to iodine contrast 18 years no limit Both Patient with severe pneumonia and atelectasis Confirmed pregnancy or suspicious of pregnancy Critically ill patient or hospitalized in ICU I26 Pulmonary embolism Diagnosis Diagnosis Intervention group: Patients suspected of pulmonary embolism referred to Shahid Faghihi Hospital (Shiraz) will be scanned by contrast agent reduction and radiation dose reduction protocol. The amount of injected contrast agent to the patients in intervention group will be 0.5 millilitre per each kilogram of body weight. The Pecnograph contains 300mgI/ml (milligram iodine per millilitre) made in Iran is the available contrast agent. This contrast agent will be used to scan patients in intervention group. These patients will be scanned by 128-MDCT Philips Ingenuity system, made in Netherland, at 100kVp. This CT system uses Iterative Reconstruction (IR) algorithm to reconstruct CT images. The pulmonary CT Angio images of patients in intervention group will be reconstructed by iDose level4 (a type of IR reconstruction), made in Netherland by Philips Company. Control group: Patients suspected of pulmonary embolism referred to Shahid Faghihi Hospital (Shiraz) will be scanned by standard protocol (pulmonary CT Angio). The amount of injected contrast agent to the patients in control group will be 1.0 millilitre per each kilogram of patient’s body weight. The Pecnograph contains 300mgI/ml (milligram iodine per millilitre) made in Iran is the available contrast agent. This contrast agent will be used to scan patients in control group. The patients in control group will be scanned by 128-MDCT Philips Ingenuity system, made in Netherland, at 100kVp. This CT system uses Iterative Reconstruction (IR) algorithm to reconstruct CT images. The pulmonary CT Angio images of patients in control group will be reconstructed by iDose level4 (a type of IR reconstruction), made in Netherland by Philips Company. The objective image quality of pulmonary CT Angio will be determined by radiologists through a scoring system. The quantitative image quality will be determined by quantitative parameters such as Signal-to-Noise Ratio. The quantity of radiation dose to the patient will be measured by the CT system. The related values will be shown on the Dose Report Page available at the end of the image series. Timepoint: The CT images will be sent to Picture Archiving and Communication System immediately after the scanning procedure completed. Then the qualitative and quantitative evaluation of the image quality of pulmonary CT Angio will perform. The results of the dose measurement will be available immediately after completing the scan. Method of measurement: Quantitative pulmonary Computed Tomography Angio (CTA) image quality will be measured by Signal-to-Noise Ratio (SNR). SNR results from the division of the mean CT density of the main pulmonary arteries (left and right) filled with contrast agent by the standard deviation of the background region (without contrast agent for example muscles surrounding the scapula). Qualitative pulmonary CT angiography is measured by the scores which are devoted to each series of images. Qualitative pulmonary CT angiography image quality will be measured by visual assessment. In this method the radiologist will use a scoring system on the basis of 5 scale scores as follow, (1) undiagnosable pulmonary CTA image (2) limited diagnostic value (3) sufficient diagnostic value (4) good image quality (5) excellent diagnostic value. Radiation dose to the patient will be measured by CT dose indices which are available on the page of dose report at the end of the CT image series. Shiraz University of Medical Sciences Approved 2022-06-21 Ethics committee of Shiraz University of Medical Sciences Research Center, 8th Floor, Mohammad Rasolallah Research Tower, Khalili street Shiraz Fars Iran (Islamic Republic of)