Pulmonary Nodule, Solitary Clinical Trial
Official title:
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.
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)).
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