Clinical trial NCT04070586: Adaptive CT Acquisition for Personalised Thoracic Imaging
Official title: ADAPT: Adaptive CT Acquisition for Personalised Thoracic Imaging: A Phase 1 Pilot Study on the Use of Respiratory Motion Guided 4DCBCT for Lung Cancer Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Lung
Keywords: Lung cancer
Radiotherapy
4DCBCT
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Liverpool Cancer Therapy Centre
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung cancer who will be treated with radiotherapy.

Brief summary: In this trial, Respiratory Motion Guided (RMG) 4DCBCT will be implemented for the first time on lung cancer patients. RMG-4DCBCT adapts the image acquisition as the patient's breathing changes (i.e. if the patient breathes faster, imaging data is acquired faster).

By adapting the acquisition to the dynamic patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.

Detailed description: Four dimensional cone beam computed tomography (4DCBCT) continues to play a pivotal role in the safe delivery of radiotherapy treatments for lung cancer patients. 4DCBCT meets exacting tumour localisation requirements by allowing radiation therapists to measure the tumour as a patient breathes (4D=volumetric images plus respiratory induced tumour motion). Despite the success of 4DCBCT to date, it suffers from relatively poor image quality, very long scan times (4min) and higher imaging doses than are necessary. The primary reason for these problems is that although the purpose of 4DCBCT is to acquire information about tumour motion due to respiration, there is no feedback from the patients breathing signal to adapt and optimise the image acquisition process. This clinical trial is a phase 1 first in human's pilot study and the aim is therefore to prove feasibility of RMG-4DCBCT, not necessarily efficacy. As such, patient scans will be acquired across a broad range of patient breathing conditions to optimise the RMG-4DCBCT technique and also to plan a hypothesis driven clinical trial to follow.

Eligibility criteria: Inclusion Criteria:

* Have the ability to give informed consent
* A diagnosis of lung cancer with an indication for radiotherapy either curative or palliative
* Radiotherapy treatment involving the routine acquisition of CBCT for patient setup provided that 4DCBCT is to be acquired during the course of treatment.
* At least two radiotherapy fractions during the course of treatment.

Exclusion Criteria:

* Pregnant women.
* Patient who in the opinion of the treating physician could not tolerate the extra time on the treatment couch for two days of treatment.

Primary outcomes:
measure: RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy
timeFrame: 2 years
Secondary outcomes:
measure: To measure the extent of association between image quality and the patients' breathing conditions.
timeFrame: 2 years
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Ricky O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lau BKF, Reynolds T, Keall PJ, Sonke JJ, Vinod SK, Dillon O, O'Brien RT. Reducing 4DCBCT imaging dose and time: exploring the limits of adaptive acquisition and motion compensated reconstruction. Phys Med Biol. 2022 Mar 7;67(6). doi: 10.1088/1361-6560/ac55a4.