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Trial registered on ANZCTR
Registration number
ACTRN12618001440213
Ethics application status
Approved
Date submitted
15/08/2018
Date registered
28/08/2018
Date last updated
28/09/2021
Date data sharing statement initially provided
30/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A non-randomised study investigating the use of imaging for radiotherapy in lung cancer patients that adapts as the patients breathing changes.
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Scientific title
ADAPT: Adaptive CT acquisition for personalised thoracic imaging: A Phase 1 Pilot Study on the Use of Respiratory Motion Guided (RMG) 4DCBCT for Lung Cancer Radiotherapy to assess the feasibility of acquiring RMG -4DCBCT for lung cancer patients undergoing radiotherapy.
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Secondary ID [1]
295817
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Nil known
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Universal Trial Number (UTN)
U1111-1219-1940
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Trial acronym
ADAPT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
309255
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Condition category
Condition code
Cancer
308127
308127
0
0
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Lung - Mesothelioma
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Cancer
308128
308128
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0
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Lung - Non small cell
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Cancer
308129
308129
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study involves the implementation of Respiratory Motion Guided (RMG) 4DCBCT 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 moving patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.
Additional equipment will be added to the radiotherapy treatment machine to allow for the RMG 4DCBCT scans. The images will be acquired on the day of treatment on two occasions (two separate days as close as possible to the beginning of the overall treatment) for 30 lung cancer patients. There is a total of 5 additional images per patient that will be acquired which means that the patient will be on the treatment couch for an additional 9 to 14 minutes in total. There is no other follow up required for the study following the acquisition of the images.
The intervention will be administrated by the treating radiation therapists and members of the medical physics team.
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Intervention code [1]
312147
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To investigate the feasibility of acquiring RMG-4DCBCT for lung cancer patients undergoing radiotherapy. Each image will be scored by 4 experienced radiation therapists on a scale (1 poor image quality to 3 good image quality). Feasibility of RMG-4DCBCT will require an average image quality score for RMG-4DCBCT higher that is higher than conventional 4DCBCT.
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Assessment method [1]
307111
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Timepoint [1]
307111
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At the end of each patients scan acquisition and end of the trial for overall comparison analysis
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Secondary outcome [1]
350920
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The proportion of patients with poor image quality for the largest and smallest 50% of patients based on hip width. Assessment is carried out after each imaging session.
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Assessment method [1]
350920
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Timepoint [1]
350920
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At the end of each patients scan acquisition and end of the trial for overall comparison analysis. This will be completed by four experienced radiation therapists who are blinded to the acquisition method. Blinding to the acquisition method will be achieved by reconstructing the images offline and presenting the images to the radiation therapists in a random order.
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Secondary outcome [2]
350921
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The proportion of patients with poor image quality for peripheral and central tumours. Assessment is carried out after each imaging session.
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Assessment method [2]
350921
0
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Timepoint [2]
350921
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At the end of each patients scan acquisition and end of the trial for overall comparison analysis. This will be completed by four experienced radiation therapists who are blinded to the acquisition method. Blinding to the acquisition method will be achieved by reconstructing the images offline and presenting the images to the radiation therapists in a random order.
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Secondary outcome [3]
350922
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The proportion of patients with poor image quality for the largest and smallest 50% of patients based on breathing amplitude. Assessment is carried out after each imaging session.
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Assessment method [3]
350922
0
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Timepoint [3]
350922
0
At the end of each patients scan acquisition and end of the trial for overall comparison analysis. This will be completed by four experienced radiation therapists who are blinded to the acquisition method. Blinding to the acquisition method will be achieved by reconstructing the images offline and presenting the images to the radiation therapists in a random order.
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Secondary outcome [4]
350923
0
The proportion of patients with poor image quality for the largest and smallest 50% of patients based on breathing period. Assessment is carried out after each imaging session.
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Assessment method [4]
350923
0
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Timepoint [4]
350923
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At the end of each patients scan acquisition and end of the trial for overall comparison analysis. This will be completed by four experienced radiation therapists who are blinded to the acquisition method. Blinding to the acquisition method will be achieved by reconstructing the images offline and presenting the images to the radiation therapists in a random order.
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Eligibility
Key inclusion criteria
18 years or older.
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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pregnant women.
Patients <18 years
Patient who in the opinion of the treating physician could not tolerate the extra time on the treatment couch for two days of treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/08/2019
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Actual
23/08/2019
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Date of last participant enrolment
Anticipated
30/11/2020
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Actual
24/12/2020
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Date of last data collection
Anticipated
30/11/2020
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Actual
13/01/2021
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
11672
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
11673
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Campbelltown Hospital - Campbelltown
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Recruitment postcode(s) [1]
23719
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2170 - Liverpool
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Recruitment postcode(s) [2]
23720
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2560 - Campbelltown
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Funding & Sponsors
Funding source category [1]
300412
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Government body
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Name [1]
300412
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National Health and Medical Research Council (NHMRC)
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Address [1]
300412
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16 Marcus Clarke St
Canberra ACT 2601
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Country [1]
300412
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
City Road,
Campberdown/Darlington
NSW 2006
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Country
Australia
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Secondary sponsor category [1]
299874
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None
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Name [1]
299874
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Address [1]
299874
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Country [1]
299874
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301217
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South Western Sydney Local Health District
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Ethics committee address [1]
301217
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Corner of Elizabeth and Goulburn Streets LIVERPOOL NSW 2170
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Ethics committee country [1]
301217
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Australia
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Date submitted for ethics approval [1]
301217
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28/09/2018
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Approval date [1]
301217
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09/10/2018
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Ethics approval number [1]
301217
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2019/ETH09968
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Summary
Brief summary
This phase 1 study will determine the feasibility of a technique that adapts imaging to patients breathing for use in radiotherapy treatments of lung cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with primary or secondary lung cancer. Study details Participants will undergo normal radiotherapy treatment with the addition of 5 imaging scans at the time of radiotherapy treatment on 2 days of treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Ricky O'Brien
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Address
86262
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University of Sydney
Room 219, Biomedical Building – C81, 1 Central Avenue, Australian Technology Park, Eveleigh, NSW, 2015
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Country
86262
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Australia
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Phone
86262
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+61 2 8627 1137
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Fax
86262
0
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Email
86262
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ricky.obrien@sydney.edu.au
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Contact person for public queries
Name
86263
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Ricky O'Brien
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Address
86263
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University of Sydney
Room 219, Biomedical Building – C81, 1 Central Avenue, Australian Technology Park, Eveleigh, NSW, 2015
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Country
86263
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Australia
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Phone
86263
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+61 2 8627 1137
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Fax
86263
0
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Email
86263
0
ricky.obrien@sydney.edu.au
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Contact person for scientific queries
Name
86264
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Ricky O'Brien
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Address
86264
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University of Sydney
Room 219, Biomedical Building – C81, 1 Central Avenue, Australian Technology Park, Eveleigh, NSW, 2015
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Country
86264
0
Australia
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Phone
86264
0
+61 2 8627 1137
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Fax
86264
0
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Email
86264
0
ricky.obrien@sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data trends will be analysed as a cohort.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Minimizing 4DCBCT imaging dose and scan time with Respiratory Motion Guided 4DCBCT: A pre-clinical investigation.
2021
https://dx.doi.org/10.1088/2057-1976/abdc82
Dimensions AI
Faster and lower dose imaging: evaluating adaptive, constant gantry velocity and angular separation in fast low-dose 4D cone beam CT imaging
2023
https://doi.org/10.1002/mp.16585
N.B. These documents automatically identified may not have been verified by the study sponsor.
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