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Completed

NCT Number: NCT04070586

Adaptive CT Acquisition for Personalised Thoracic Imaging

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4DCBCT images

Device

Images are acquired and assessed offline

Primary outcomes

  1. 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

  1. To measure the extent of association between image quality and the patients' breathing conditions.

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Liverpool Cancer Therapy Centre
  • National Health and Medical Research Council, Australia

Registry information

Official study 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

Acronym: ADAPT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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