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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04070586




Registration number
NCT04070586
Ethics application status
Date submitted
13/08/2019
Date registered
28/08/2019
Date last updated
19/05/2021

Titles & IDs
Public title
Adaptive CT Acquisition for Personalised Thoracic Imaging
Scientific 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
Secondary ID [1] 0 0
HREC/18/LPOOL/361
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - 4DCBCT images

4DCBCT images - 4DCBCT images are acquired and assessed offline.


Treatment: Devices: 4DCBCT images
Images are acquired and assessed offline
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
To measure the extent of association between image quality and the patients' breathing conditions.
Timepoint [1] 0 0
2 years

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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/02/2021
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Liverpool Cancer Therapy Centre
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04070586
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ricky O'Brien, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04070586