Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000163505
Ethics application status
Approved
Date submitted
3/02/2015
Date registered
19/02/2015
Date last updated
18/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) guided audiovisual biofeedback for precise lung cancer radiotherapy
Scientific title
To evaluate the reproducibility of respiratory-related tumour motion in lung cancer patients using the MRI guided audiovisual biofeedback (MRI-AV) system
Secondary ID [1] 286088 0
Nil Known
Universal Trial Number (UTN)
U1111-11667876
Trial acronym
AVATAR (Audio-Visual biofeedbAck for Tumour motion regulARity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 294089 0
Lung tumour motion consistency throughout medical imaging and radiotherapy procedures 294090 0
Condition category
Condition code
Cancer 294397 294397 0 0
Lung - Non small cell
Cancer 294398 294398 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lung tumor motion was investigated in lung cancer patients who underwent a breathing training session with AV biofeedback prior to two 3T MRI sessions. The breathing training session was performed to allow patients to become familiar with an AV biofeedback, which utilizes a guiding wave customized for each patient based on a reference breathing pattern. This training session takes approximately 10 minutes. In the first MRI session (pre-treatment) 2D/3D/4D MR images with (1) free breathing (FB) and (2) AV biofeedback were obtained and the second MRI session was repeated within 3 to 6 weeks (mid-treatment). Each MRI session takes approximately 2 hours to perform. All imaging protocols used are already approved clinical procedures.
Intervention code [1] 291081 0
Treatment: Devices
Comparator / control treatment
Free or normal breathing versus breathing using MRI-AV biofeedback guidance
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294198 0
Tumour motion reproducibility with and without MRI guided audiovisual biofeedback. Results will be evaluated using the root mean square error (RMSE) method and compared using statistical analysis methods such as the students t-test.
Timepoint [1] 294198 0
After a minimum of 15 participants have been recruited. The primary outcome will be assessed following the second MRI session (mid treatment) for each participant.
Secondary outcome [1] 312741 0
Clinical benefit assessed as change in dose delivered to healthy tissues as a result of changes in tumour margins due to more consistant tumor motion achieved with four-dimensional MRI. MRI scans obtained before the start of radiotherapy and during radiotherapy treatment will be used. The treatment planning will be evaluated qualitatively by visual inspection of dose distribution and quantatively by analysing dose-volume metrics derived from dose-volume histograms (DVHs) and functional DVHs.
Timepoint [1] 312741 0
End of recruitment. This outcome will also be assessed following the second MRI session (mid treatment) for each participant.

Eligibility
Key inclusion criteria
Stage I-III lung cancer of any histology to be treated with radical radiotherapy with or without chemotherapy
Ability to have radiological scans, no contraindications to having an MRI scan
Ability to lie flat for about 1 hour 10 minutes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic disease
Pregnant women or those mentally impaired
People highly dependent on medical care
People unable to undergo MRI exam

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
According to the preliminary results with 15 healthy human subjects, assuming a type I error rate of 5%, 80% power and a moderate effect size of 0.512 SD for the paired differences between free breathing and MRI-AV biofeedback, a sample size of 15 patients will be required. If we assume that the standard deviations of those differences will be approximately double that of healthy volunteers then the minimal detectable difference will be 0.144 for the diaphragm RMSE in displacement (SD = 0.2). The study will involve consecutive 15 lung cancer participants per system development stage (a total of 60 lung cancer patients).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2013
Actual
2/04/2013
Date of last participant enrolment
Anticipated
26/02/2016
Actual
23/12/2015
Date of last data collection
Anticipated
Actual
19/04/2016
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3396 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 9179 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 290679 0
Government body
Name [1] 290679 0
NHMRC Australian Fellowship
Country [1] 290679 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Radiation Physics Laboratory
Sydney Medical School
Room 474 Blackburn Building D06
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 289372 0
Hospital
Name [1] 289372 0
Calvary Mater Newcastle
Address [1] 289372 0
Radiation Oncology
Edith Street
Waratah NSW 2298
Country [1] 289372 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292310 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292310 0
Ethics committee country [1] 292310 0
Australia
Date submitted for ethics approval [1] 292310 0
Approval date [1] 292310 0
06/02/2013
Ethics approval number [1] 292310 0
HREC/12/HNE/414

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54570 0
Prof Paul Keall
Address 54570 0
Radiation Physics Laboratory
Sydney Medical School
Room 474
Blackburn Building D06
University of Sydney NSW 2006
Country 54570 0
Australia
Phone 54570 0
+61 2 93513385
Fax 54570 0
+ 61 2 93514018
Email 54570 0
[email protected]
Contact person for public queries
Name 54571 0
Joanne Smart
Address 54571 0
Clinical Trial Coordinator Radiation Oncology Calvary Mater Newcastle Edith Street Waratah NSW 2298
Country 54571 0
Australia
Phone 54571 0
+61 2 40143947
Fax 54571 0
+61 2 40143945
Email 54571 0
[email protected]
Contact person for scientific queries
Name 54572 0
Paul Keall
Address 54572 0
Radiation Physics Laboratory
Sydney Medical School
Room 474
Blackburn Building D06
University of Sydney NSW 2006
Country 54572 0
Australia
Phone 54572 0
+61 2 93513385
Fax 54572 0
+ 61 2 93514018
Email 54572 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.