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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
Date results information initially provided
28/09/2021
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.
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.
Secondary ID [1] 295817 0
Nil known
Universal Trial Number (UTN)
U1111-1219-1940
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 309255 0
Condition category
Condition code
Cancer 308127 308127 0 0
Lung - Mesothelioma
Cancer 308128 308128 0 0
Lung - Non small cell
Cancer 308129 308129 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312147 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307111 0
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.
Timepoint [1] 307111 0
At the end of each patients scan acquisition and end of the trial for overall comparison analysis
Secondary outcome [1] 350920 0
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.
Timepoint [1] 350920 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.
Secondary outcome [2] 350921 0
The proportion of patients with poor image quality for peripheral and central tumours. Assessment is carried out after each imaging session.
Timepoint [2] 350921 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.
Secondary outcome [3] 350922 0
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.
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.
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.
Timepoint [4] 350923 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.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11672 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 11673 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 23719 0
2170 - Liverpool
Recruitment postcode(s) [2] 23720 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 300412 0
Government body
Name [1] 300412 0
National Health and Medical Research Council (NHMRC)
Address [1] 300412 0
16 Marcus Clarke St
Canberra ACT 2601
Country [1] 300412 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Road,
Campberdown/Darlington
NSW 2006
Country
Australia
Secondary sponsor category [1] 299874 0
None
Name [1] 299874 0
Address [1] 299874 0
Country [1] 299874 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301217 0
South Western Sydney Local Health District
Ethics committee address [1] 301217 0
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Ethics committee country [1] 301217 0
Australia
Date submitted for ethics approval [1] 301217 0
28/09/2018
Approval date [1] 301217 0
09/10/2018
Ethics approval number [1] 301217 0
2019/ETH09968

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86262 0
A/Prof Ricky O'Brien
Address 86262 0
University of Sydney
Room 219, Biomedical Building – C81, 1 Central Avenue, Australian Technology Park, Eveleigh, NSW, 2015
Country 86262 0
Australia
Phone 86262 0
+61 2 8627 1137
Fax 86262 0
Email 86262 0
ricky.obrien@sydney.edu.au
Contact person for public queries
Name 86263 0
A/Prof Ricky O'Brien
Address 86263 0
University of Sydney
Room 219, Biomedical Building – C81, 1 Central Avenue, Australian Technology Park, Eveleigh, NSW, 2015
Country 86263 0
Australia
Phone 86263 0
+61 2 8627 1137
Fax 86263 0
Email 86263 0
ricky.obrien@sydney.edu.au
Contact person for scientific queries
Name 86264 0
A/Prof Ricky O'Brien
Address 86264 0
University of Sydney
Room 219, Biomedical Building – C81, 1 Central Avenue, Australian Technology Park, Eveleigh, NSW, 2015
Country 86264 0
Australia
Phone 86264 0
+61 2 8627 1137
Fax 86264 0
Email 86264 0
ricky.obrien@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data trends will be analysed as a cohort.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary