Adaptive CT Acquisition for Personalised Thoracic Imaging

Cancer, Lung Clinical Trial

— ADAPT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070586
• Other study ID #: HREC/18/LPOOL/361
• Status: Completed
• Start date: August 21, 2019
• Est. completion date: February 19, 2021

Study information

• Verified date: May 2021
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 19, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer, Lung
• Lung Neoplasms

Intervention

Device:
• 4DCBCT images
Images are acquired and assessed offline

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
University of Sydney	Liverpool Cancer Therapy Centre, National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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