Adaptive CT Acquisition for Personalised Thoracic Imaging (ADAPT)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer, Lung
• Intervention / Treatment: Device: 4DCBCT images

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer who will be treated with radiotherapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
4DCBCT images; 4DCBCT images are acquired and assessed offline.	Device: 4DCBCT images; Images are acquired and assessed offline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy	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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the extent of association between image quality and the patients' breathing conditions.	Using RMG-4DCBCT scans acquired across a broad range of patients for the first time we will determine if there is a link between image quality and the patients' breathing conditions. This information will be used to improve the prototype.	2 years

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: National Health and Medical Research Council, Australia; Liverpool Cancer Therapy Centre
• Investigators: Principal Investigator: Ricky O'Brien, PhD, University of Sydney

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): February 19, 2021

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Lung cancer; Radiotherapy; 4DCBCT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HREC/18/LPOOL/361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only non-identifiable data may be made available for other scientific research, e.g., nonidentifiable data placed on a well-controlled university site, upon request. The data sharing platform is a secure on-line storage solution ("CloudStor") provided through University of Sydney. The data will be stored as a password-protected, encrypted file. In order to download or decompress the data, participating researchers agree to the terms of use for the data, including: (i) that the data is not to be published or otherwise redistributed without the express consent of the original investigators.
• IPD Sharing Time Frame: Data will become available following completion of the final analysis. Data will be available indefinitely.
• IPD Sharing Access Criteria: Data will be made available to other researchers upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No