NCT04070586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

August 13, 2019

Last Update Submit

May 18, 2021

Conditions

Keywords

Lung cancerRadiotherapy4DCBCT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    2 years

Study Arms (1)

4DCBCT images

4DCBCT images are acquired and assessed offline.

Device: 4DCBCT images

Interventions

Images are acquired and assessed offline

4DCBCT images

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lung cancer who will be treated with radiotherapy.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ricky O'Brien, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 28, 2019

Study Start

August 21, 2019

Primary Completion

January 13, 2021

Study Completion

February 19, 2021

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will become available following completion of the final analysis. Data will be available indefinitely.
Access Criteria
Data will be made available to other researchers upon request.

Locations