Cancer, LungADAPTNCT04070586
Adaptive CT Acquisition for Personalised Thoracic Imaging
An observational study of Cancer, Lung, run by University of Sydney at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung
- What is being tested?
- 4DCBCT images
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Aug 2019to 19 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung cancer who will be treated with radiotherapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cancer, Lung
- Being tested
- 4DCBCT images
- Keywords
- Lung cancer, Radiotherapy, 4DCBCT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4DCBCT imagesDevice
Images are acquired and assessed offline
| Study group | Role | What they receive |
|---|---|---|
| 4DCBCT images | 4DCBCT images are acquired and assessed offline. Receives: Device: 4DCBCT images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start21 Aug 2019
- Primary completion13 Jan 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Liverpool Cancer Therapy Centre
- Responsible party
- Sponsor
- Investigators
- Ricky O'Brien, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070586
- Sponsor's protocol ID
- HREC/18/LPOOL/361
- Acronym
- ADAPT
- Status last verified
- May 2021
- First submitted
- 13 Aug 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35172286
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04070586
- Acronym / sponsor ID
- ADAPT / HREC/18/LPOOL/361
- Conditions
- Cancer, Lung
- Keywords
- Lung cancer, Radiotherapy, 4DCBCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Liverpool Cancer Therapy Centre
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4DCBCT images | – | Device: 4DCBCT images4DCBCT images are acquired and assessed offline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer who will be treated with radiotherapy.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4DCBCT imagesImages are acquired and assessed offline | Device | 4DCBCT images |
Primary outcome
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).
1 secondary outcome
To measure the extent of association between image quality and the patients' breathing conditions.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 35172286Lau 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricky O'Brien, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Lung, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.