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

NCT04209972 | Completed DMC

• 1 other identifier: NL67905.091.18
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Nodule, Solitary

Keywords

Ultra-high resolution CT; volume measumerents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of image quality (segmentation errors)

  5 months

• Evaluation of image quality (motion artefacts)

  5 months

Other Outcomes (4)

• Patient characteristics (age)

  4 months

• Patient characteristics (height)

  4 months

• Patient characteristics (weight)

  4 months

Study Arms (2)

Patients on CT1

ACTIVE COMPARATOR

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 on CT2

ACTIVE COMPARATOR

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

Interventions

Precision Ultra-High-Resolution CT scanner DEVICE

Patients will be divided on one of the two CT scanners. This group will be scanned on the Precision CT scanner.

Patients on CT2

Genesis high-end CT scanner DEVICE

Patients will be divided on one of the two CT scanners. This group will be scanned on the Aquilion one Genesis.

Patients on CT1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (17)

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  PMID: 28240562 RESULT

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  PMID: 26135833 RESULT

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  PMID: 14615902 RESULT

• 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.

  PMID: 17923508 RESULT

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  PMID: 16554568 RESULT

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  PMID: 18773240 RESULT

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  PMID: 29627067 RESULT

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  PMID: 28392613 RESULT

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  PMID: 26466180 RESULT

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Monique Brink, PhD, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients does not know if he is on the standard CT scanner, or on the UHR CT scanner
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups, 40 patients on one CT scanner, 40 different patients on the other CT scanner.

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: December 24, 2019
• Study Start: March 11, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-03

Locations

NL (1)