Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209972
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Nodule, Solitary Device: Precision Ultra-High-Resolution CT scanner Device: Genesis high-end CT scanner Not Applicable

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)).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups, 40 patients on one CT scanner, 40 different patients on the other CT scanner.
Masking: Single (Participant)
Masking Description: Patients does not know if he is on the standard CT scanner, or on the UHR CT scanner
Primary Purpose: Diagnostic
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

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluation of image quality (segmentation errors) [ Time Frame: 5 months ]
    Evaluate the image quality of the scans

  2. Evaluation of image quality (motion artefacts) [ Time Frame: 5 months ]
    Evaluate the image quality of the scans


Other Outcome Measures:
  1. Patient characteristics (age) [ Time Frame: 4 months ]
    Patient characteristics (age)

  2. Patient characteristics (height) [ Time Frame: 4 months ]
    Patient characteristics (height)

  3. Patient characteristics (weight) [ Time Frame: 4 months ]
    Patient characteristics (weight)

  4. Radiation dose [ Time Frame: 4 months ]
    Radiation dose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209972


Locations
Layout table for location information
Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Layout table for investigator information
Principal Investigator: Monique Brink, PhD, MD Radboud University
Publications of Results:

Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04209972    
Other Study ID Numbers: NL67905.091.18
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not decided yet

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Ultra-high resolution CT
volume measumerents
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases