The Benefit of UHR-CT: Precision of Repeated Volume Measurements of Pulmonary Nodules

Pulmonary Nodule, Solitary Clinical Trial

— Coffee Break  

Official title:

The Benefit of Ultra-high Resolution Computed Tomography: Precision of Repeated Volume Measurements of Pulmonary Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209972
• Other study ID #: NL67905.091.18
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: March 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the variability of semi-automated volume measurements of pulmonary nodules on same-day repeated scans of equal radiation dose from two different CT scanners: One high-end CT scanner with standard spatial resolution (CT1) and one UHRCT scanner (CT2), in patients with known or suspected pulmonary metastases.

Description:

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• 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:

• Immobility (not able to stand up and get off the scanner table)

• 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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (17)

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. Review. — View Citation

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. Review. — View Citation

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation

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 examina — View Citation

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. — View Citation

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. Review. — View Citation

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. 20 — View Citation

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. — View Citation

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. Review. — View Citation

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) — View Citation

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. — View Citation

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. pii: 101320Y. doi: 10 — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. Epub 2003 Nov 13. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics (age)	Patient characteristics (age)	4 months
Other	Patient characteristics (height)	Patient characteristics (height)	4 months
Other	Patient characteristics (weight)	Patient characteristics (weight)	4 months
Other	Radiation dose	Radiation dose	4 months
Primary	The main endpoint of this study is the difference in precision in millimeter between the two CT scanners.	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	4 months
Secondary	Evaluation of image quality (segmentation errors)	Evaluate the image quality of the scans	5 months
Secondary	Evaluation of image quality (motion artefacts)	Evaluate the image quality of the scans	5 months