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…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
* To assess the variability in manual calliper two-dimensional measurements of
pulmonary nodules.
* To assess the effect of subjective image quality, structure delineation and
segmentation, and nodule type on the variability in volume of the nodule
measurements.
Background summary
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.
Study 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 burden and risks
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)).
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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:
o Radiotherapy
o Excision
o Ablation
* Patients with radiologically suspected lymphangitis carcinomatosa or consolidations around the nodules.
* Patients who only have calcified pulmonary nodules or nodules that about vessels or pleura.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67905.091.18 |