Respiratory Adaptive Computed Tomography: Feasibility Study on Real-Time Gated 4DCT for Lung Cancer Radiotherapy

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Real-time Gated 4DCT

    Diagnostic test

    Real-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 test

    Four-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

30 Participants
are divided into 1 treatment group
Group A: Real-Time Gated 4DCT and Conventional 4DCTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
30 minutes

Secondary outcomes

1

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.)

Time frame
1 minute at end of planning session
2

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.

Time frame
5 minutes at end of planning session
3

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.

Time frame
5-10 minutes, following delineation of standard care and study scans.
4

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).

Time frame
40 minutes, prior to and during the planning session

Other outcomes

Sponsors and contacts

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University of Sydney

Lead sponsor

Western Sydney Local Health District

Collaborator