The Benefit of UHR-CT: Precision of Repeated Volume Measurements of Pulmonary Nodules
NCT ID: NCT04209972
Last Updated: 2019-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2019-03-11
2019-07-30
Brief Summary
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Detailed Description
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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)).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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)
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.
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)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* A solid primary tumour anywhere in the body and solid, noncalcified nodules in the pulmonary parenchyma on previous CT scans suspected for pulmonary metastases, according to radiological reports
* Two lung nodules that do not abut vessels or pleura with a two dimensional diameter between 5 and 10 mm within a distance of each other of 16 cm in the craniocaudal direction
Exclusion Criteria
* Patients who received local pulmonary treatment: Radiotherapy, Excision, Ablation
* Patients with radiologically suspected lymphangitis carcinomatosa or consolidations around the nodules.
* Patients who only have calcified pulmonary nodules or nodules that abut vessels or pleura.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Monique Brink, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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References
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van der Molen AJ, Schilham A, Stoop P, Prokop M, Geleijns J. A national survey on radiation dose in CT in The Netherlands. Insights Imaging. 2013 Jun;4(3):383-90. doi: 10.1007/s13244-013-0253-9. Epub 2013 May 15.
Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology. 2010 Oct;257(1):158-66. doi: 10.1148/radiol.10100047.
Alpert JB, Ko JP. Management of Incidental Lung Nodules: Current Strategy and Rationale. Radiol Clin North Am. 2018 May;56(3):339-351. doi: 10.1016/j.rcl.2018.01.002. Epub 2018 Mar 7.
MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.
Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.
Devaraj A, van Ginneken B, Nair A, Baldwin D. Use of Volumetry for Lung Nodule Management: Theory and Practice. Radiology. 2017 Sep;284(3):630-644. doi: 10.1148/radiol.2017151022.
Wormanns D, Kohl G, Klotz E, Marheine A, Beyer F, Heindel W, Diederich S. Volumetric measurements of pulmonary nodules at multi-row detector CT: in vivo reproducibility. Eur Radiol. 2004 Jan;14(1):86-92. doi: 10.1007/s00330-003-2132-0. Epub 2003 Nov 13.
Gietema HA, Schaefer-Prokop CM, Mali WP, Groenewegen G, Prokop M. Pulmonary nodules: Interscan variability of semiautomated volume measurements with multisection CT-- influence of inspiration level, nodule size, and segmentation performance. Radiology. 2007 Dec;245(3):888-94. doi: 10.1148/radiol.2452061054. Epub 2007 Oct 8.
Goodman LR, Gulsun M, Washington L, Nagy PG, Piacsek KL. Inherent variability of CT lung nodule measurements in vivo using semiautomated volumetric measurements. AJR Am J Roentgenol. 2006 Apr;186(4):989-94. doi: 10.2214/AJR.04.1821.
Hein PA, Romano VC, Rogalla P, Klessen C, Lembcke A, Bornemann L, Dicken V, Hamm B, Bauknecht HC. Variability of semiautomated lung nodule volumetry on ultralow-dose CT: comparison with nodule volumetry on standard-dose CT. J Digit Imaging. 2010 Feb;23(1):8-17. doi: 10.1007/s10278-008-9157-5. Epub 2008 Sep 5.
Han D, Heuvelmans MA, Oudkerk M. Volume versus diameter assessment of small pulmonary nodules in CT lung cancer screening. Transl Lung Cancer Res. 2017 Feb;6(1):52-61. doi: 10.21037/tlcr.2017.01.05.
Tanaka R, Yoshioka K, Takagi H, Schuijf JD, Arakita K. Novel developments in non-invasive imaging of peripheral arterial disease with CT: experience with state-of-the-art, ultra-high-resolution CT and subtraction imaging. Clin Radiol. 2019 Jan;74(1):51-58. doi: 10.1016/j.crad.2018.03.002. Epub 2018 Apr 5.
Zhou W, Montoya J, Gutjahr R, Ferrero A, Halaweish A, Kappler S, McCollough C, Leng S. Lung Nodule Volume Quantification and Shape Differentiation with an Ultra-High Resolution Technique on a Photon Counting Detector CT System. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10132:101323Q. doi: 10.1117/12.2255736. Epub 2017 Mar 9.
de Hoop B, Gietema H, van Ginneken B, Zanen P, Groenewegen G, Prokop M. A comparison of six software packages for evaluation of solid lung nodules using semi-automated volumetry: what is the minimum increase in size to detect growth in repeated CT examinations. Eur Radiol. 2009 Apr;19(4):800-8. doi: 10.1007/s00330-008-1229-x. Epub 2008 Nov 19.
Leng S, Gutjahr R, Ferrero A, Kappler S, Henning A, Halaweish A, Zhou W, Montoya J, McCollough C. Ultra-High Spatial Resolution, Multi-Energy CT using Photon Counting Detector Technology. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10132:101320Y. doi: 10.1117/12.2255589. Epub 2017 Mar 9.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Kalra MK, Sodickson AD, Mayo-Smith WW. CT Radiation: Key Concepts for Gentle and Wise Use. Radiographics. 2015 Oct;35(6):1706-21. doi: 10.1148/rg.2015150118.
Other Identifiers
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NL67905.091.18
Identifier Type: -
Identifier Source: org_study_id