The Benefit of UHR-CT: Precision of Repeated Volume Measurements of Pulmonary Nodules (Coffee Break)
|ClinicalTrials.gov Identifier: NCT04209972|
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Nodule, Solitary||Device: Precision Ultra-High-Resolution CT scanner Device: Genesis high-end CT scanner||Not Applicable|
Rationale: Ultra-high resolution computed tomography (UHRCT) produces radiological images with a spatial resolution of 0.25 mm in a matrix of 1024x1024. This should decrease measurement variation of nodule growth as a marker of malignancy, by making nodule delineation more precise for automatic volumetry segmentation and volume doubling time assessment than in conventional CT. If possible, this can shorten follow up of incidental pulmonary nodules to exclude malignancy, with less medicalisation and patient anxiety.
Objective: To assess the variability of semi-automated volume measurements of pulmonary nodules in patients with known or suspected pulmonary metastases on same-day repeated scans of equal radiation dose from two different CT scanners: CT scanner with standard spatial resolution (conventional CT, CT1) and UHRCT (CT2).
Study design: This is a single center prospective trial on 80 patients with known or suspected pulmonary metastases who are scheduled for chest and/or abdominal CT. Study participants will undergo two additional partial chest CT scans on either CT 1 or CT 2 for research purpose only, at similar radiation dose. Patients are equally divided across CT 1 and 2.
Study population: Patients who are 18 years or older with known solid pulmonary nodules compatible with metastases and who are willing and able to give informed consent are eligible. Patients are excluded if they have less than two eligible pulmonary nodules with a z range of 16 cm. Nodules with calcifications, surrounding opacities, or vessel- or pleural abutment will be excluded from analysis.
Main study parameters/endpoints: The main endpoint of this study is the upper limit of the 95% confidence interval of repeated semi-automated nodule volume measurements of both CT scanners.
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 ionizing radiation. The CT protocol including the scheduled CT scan and the additional scans in this study has been carefully designed to have a total radiation dose at the same level as the achievable diagnostic reference level of chest CT in the Netherlands, which is 542 mGycm in 2013 (1). The burden associated with the two extra study CT acquisitions comprises a dose length product (DLP) of 120.4 mGy•cm for research (1.7 mSv, which is lower than the background radiation of one year in the Netherlands, with a conversion factor of 0.014 from Deak et al (2)).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 groups, 40 patients on one CT scanner, 40 different patients on the other CT scanner.|
|Masking Description:||Patients does not know if he is on the standard CT scanner, or on the UHR CT scanner|
|Official Title:||The Benefit of Ultra-high Resolution Computed Tomography: Precision of Repeated Volume Measurements of Pulmonary Nodules|
|Actual Study Start Date :||March 11, 2019|
|Actual Primary Completion Date :||July 30, 2019|
|Actual Study Completion Date :||July 30, 2019|
Active Comparator: Patients on CT1
Patients will undergo two pre-contrast scans, and will be in between the two scans be off and on the table at a standard CT scanner. (Aquilion One Genesis, Canon Medical Systems)
Device: Genesis high-end CT scanner
Patients will be divided on one of the two CT scanners. This group will be scanned on the Aquilion one Genesis.
Active Comparator: Patients on CT2
Patients will undergo two pre-contrast scans, and will be in between the two scans be off and on the table at a UHRCT scanner. (Aquilion One Precision, Canon Medical Systems)
Device: Precision Ultra-High-Resolution CT scanner
Patients will be divided on one of the two CT scanners. This group will be scanned on the Precision CT scanner.
- The main endpoint of this study is the difference in precision in millimeter between the two CT scanners. [ Time Frame: 4 months ]The precision of each scanner is obtained by the standard deviation between the two measurements. The difference between scanners is tested with an F-test and the precision of each scanner is shown by a Bland-Altman plot
- Evaluation of image quality (segmentation errors) [ Time Frame: 5 months ]Evaluate the image quality of the scans
- Evaluation of image quality (motion artefacts) [ Time Frame: 5 months ]Evaluate the image quality of the scans
- Patient characteristics (age) [ Time Frame: 4 months ]Patient characteristics (age)
- Patient characteristics (height) [ Time Frame: 4 months ]Patient characteristics (height)
- Patient characteristics (weight) [ Time Frame: 4 months ]Patient characteristics (weight)
- Radiation dose [ Time Frame: 4 months ]Radiation dose
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209972
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||Monique Brink, PhD, MD||Radboud University|