About this trial
This study does not involve a therapeutic intervention as standard radiation therapy treatment will be prescribed. This study involves one additional 4DCT scan (i.e. the Real-Time Gated 4DCT scan) acquired immediately before or following the conventional 4DCT scan. This will take place on the day of the patient's treatment simulation, as per the current standard of care. The scanning sequence (i.e. conventional first versus gated first) will be randomised.
The Real-Time Gated 4DCT is anticipated to take longer than the conventional 4DCT scan, due to its gated (beam-pause) nature. However, upper limits for timing will be implemented in the software, and the scan aborted for highly erratic breathing traces that would not benefit from a Real-Time Gated 4DCT scan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Have the ability to give informed consent
A diagnosis of lung cancer with an indication for radiation therapy
Radiation therapy treatment involving the acquisition of a 4DCT scan for treatment planning
Disqualifiers
Pregnant women
Patients <18 years
Patients who in the opinion of the treating physician could not tolerate the extra time on the CT couch for an extra scan
Trial design
Single group
Treatments tested in this trial
Real-time Gated 4DCT
Diagnostic testReal-time gated four-dimensional cone beam computed tomography (4DCT) will be conducted at the simulation session. The Real-Time Gated 4DCT will be conducted while the patient moves through the rotating X-ray imager. This method detects and then pauses the CT beam during irregular breathing events.
Conventional 4DCT
Diagnostic testFour-dimensional computed tomography (4DCT), the standard of care for modern high-precision stereotactic ablative body radiotherapy (SABR), will be conducted at the simulation session. It will run continuously while the patient moves through the rotating X-ray imager.
Treatment groups
Trial outcomes
Primary outcomes
The feasibility of using Real-Time Gated 4DCT instead of Conventional 4DCT for planning radiotherapy for lung cancer.
A change in the anticipated rate of image artifacts in images acquired from Conventional of 60% to 35% or less in images acquired from Real-Time Gated 4DCT.
Secondary outcomes
Patient tolerance to the experimental scan (Real-Time Gated 4DCT)
The radiation therapist conducting the radiation therapy study scan will complete a survey consisting of two yes/no questions after the planning session to assess patient tolerance (1. whether the patient finishes the scan without getting off the couch. 2. If the patient voiced any complaints during the scan and seem uncomfortable.)
clinician confidence in acquiring a Real-Time Gated 4DCT scan
The radiation therapist conducting the radiation therapy study scan will complete an in-house survey of 10 questions after the treatment session to evaluate their experience with REACT software and its usability.
clinician confidence in delineation on a Real-Time Gated 4DCT scan
The radiation oncologist performing the delineation on the radiation therapy planning scan images and study scan images will complete an in-house survey of 10 questions to evaluate his experience with REACT and his confidence with using REACT for delineation.
Effect on Real-Time Gated 4DCT image quality of patient characteristics: breathing type, breathing period, BMI, tumour location, breathing amplitude, breathing regularity, pulmonary function, ECOG status.
Correlation between image quality (the number of artifacts greater than 4mm in the images acquired from Real-Time Gated 4DCT) and participant characteristics known to affect image quality in conventional scans: Breathing period ( seconds) and breathing amplitude will be measured using the Varian real-time position management system; body mass index (weight(kg) x height(m)2); tumour location;, breathing regularity (root mean square error (RMSE) of 6 breaths/min was obtained), pulmonary function, Performance status (Eastern Cooperative Oncology Group (ECOG) performance scale).
Sponsors and contacts
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University of Sydney
Lead sponsor
Western Sydney Local Health District
Collaborator