The Benefit of UHR-CT: Precision of Repeated Volume Measurements of Pulmonary Nodules (Coffee Break)

December 23, 2019 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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)).

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of image quality (segmentation errors)
Time Frame: 5 months
Evaluate the image quality of the scans
5 months
Evaluation of image quality (motion artefacts)
Time Frame: 5 months
Evaluate the image quality of the scans
5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics (age)
Time Frame: 4 months
Patient characteristics (age)
4 months
Patient characteristics (height)
Time Frame: 4 months
Patient characteristics (height)
4 months
Patient characteristics (weight)
Time Frame: 4 months
Patient characteristics (weight)
4 months
Radiation dose
Time Frame: 4 months
Radiation dose
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Monique Brink, PhD, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL67905.091.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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