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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sydney
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy
Time Frame: 2 years
This will be achieved by performing (offline) analysis of the RMG-4DCBCT images obtained and scoring them on a scale of one (excellent quality for image guidance) to three (unsuitable for image guidance).
Secondary Outcomes
- To measure the extent of association between image quality and the patients' breathing conditions.(2 years)