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Trial registered on ANZCTR


Registration number
ACTRN12612000775819
Ethics application status
Approved
Date submitted
4/07/2012
Date registered
23/07/2012
Date last updated
3/02/2022
Date data sharing statement initially provided
3/02/2022
Date results provided
3/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating computed tomography ventilation as a functional imaging modality for lung cancer radiotherapy
Scientific title
Investigating computed tomography ventilation as a functional imaging modality for lung cancer radiotherapy in minimising radiation toxicity
Secondary ID [1] 280340 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiotherapy toxicity in lung cancer radiotherapy 286300 0
Condition category
Condition code
Cancer 286545 286545 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a validation study of utilising respiratory correlated computed tomography (CT) imaging (e.g, four dimensional CT) in obtaining the distribution of lung ventilation. The CT ventilation imaging will be validated with the gold standard in ventilation imaging, nuclear medicine ventilation imaging. The study participants will undergo (1) a CT imaging session where a four dimensional CT, a static end-inspiration breath hold CT and an end-expiration breath hold CT will be acquired and (2) a nuclear medicine imaging session where a PET-Galligas (alternative will be SPECT-Technegas) ventilation scan will be acquired. The CT ventilation images will then be used to create a functional based radiotherapy treatment plan. A standard anatomical based treatment plan will also be created which the functional based treatment plan will be compared to. We will estimate the difference in dose to the functional lungs (toxicity) between the standard of care anatomical based treatment plan used in radiotherapy planning and the study's functional based treatment plans. Neither of these plans will be used in the any of the study participants' treatments. Summary of imaging scans to be collected per study participant: Two static breath hold CT scans one collected after inhalation and the other after exhalation, One four-dimensional-CT (4D-CT) scan, One Nuclear Medicine ventilation scan (PET-Galligas or SPECT-Technegas). All CT scans will be obtained on the same day in one session on a dual modality PET/CT machine taking approximately 1.5 hour in total to complete. These scans will be collected only once in the study. The static breath hold CT scans will require the patient to hold their breath for 20 seconds during the scan acquisition. Each of the static breath hold CT scans will take less than 1 minute to complete. The 4D-CT scan will take approximately 3 minutes to complete. The nuclear medicine scan will take approximately 15 minutes to complete. In all the scans outlined above the participant will be asked to lie on their back with their arms above their head for the duration the scans. All the scans will be acquired with the use of a respiratory regulator system called the Audiovisual Biofeedback system. The Audiovisual Biofeedback system requires the participant to wear electronic goggles which will display their breathing pattern in the shape of a wave and they will be guided to maintain regular breathing by following the wave pattern during the image acquisitions. The total dose received from all scans in study will be approximately 50 - 70 mSv. The study will be accrue 30 patients over the period of 3 years. This study is specifically aimed at lung cancer patients. As this is not a treatment based study and the data is collected in the treatment phase, the study is open to non-RT treated lung cancer patients, chemotherapy patients. Patients will fall into two groups, the majority of study patients will fall into the RT group (i.e., patients that are to be treated with RT) and a small number of patients will fall into the Non-RT group (i.e., patients treated with chemotherapy). RT Group: Stage I - IV Non-RT Group: Stage IIIB, IV (patients greater than or equal to 65 years old)
Intervention code [1] 284769 0
Diagnosis / Prognosis
Intervention code [2] 284771 0
Treatment: Other
Comparator / control treatment
A standard treatment plan (anatomical based) will be generated for each patient which will be compared to the functional based radiotherapy plan created using the CT ventilation images.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286977 0
The physiological accuracy of CT ventilation imaging. This is going to be assessed via an imaging voxel-based correlation study between CT ventilation images and the nuclear medicine ventilation images (PET-Galligas or SPECT-Technegas), where SPECT-Technegas is recognised as being the gold standard in ventilation imaging. Deformable image registration (DIR) algorithms will be used to optimise the CT ventilation images to best match the nuclear medicine ventilation image. A correlation criteria of atleast 0.8 will be sought if possible which will signify physiological accuracy.
Timepoint [1] 286977 0
Within 2 weeks of initial consultation from medical specialist (Respiratory Physicians or Radiation Oncologists) at Royal North Shore Hospital.
Secondary outcome [1] 297095 0
The dosimetric impact of CT ventilation imaging in radiotherapy. The mean dose to the functional lung regions for each treatment plan will be estimated and will be compared to the mean dose estimated from a standard anatomical based radiotherapy plan. We hypothesise that a significant reduction in dose will be achieved using functional based planning from CT ventilation imaging.
Timepoint [1] 297095 0
Anytime after imaging sessions are complete within the 3 yr time frame of the overall study duration.

Eligibility
Key inclusion criteria
This study is specifically aimed at lung cancer patients. Patients will fall into two groups, the majority of study patients will fall into the RT group (i.e, patients that are to be treated with radiotherapy) and a small number of patients will fall into the Non-RT group (i.e., patients that are not going to receive RT treatment and therefore will most probably be receiving chemotherapy).
RT Group: Stage I - IV patients treated with any type of RT
Non-RT group: Stage IIIB, IV (patients greater than or equal to 65 years old)

The ability to understand and willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No pregnant women
2. children or young people <18 yrs
3.Curative intent patients for radiotherapy (other than SBRT treated)
4. Curative intent non-radiotherapy patients
5. No decisionally challenged individuals
6. People highly dependent on medical care

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients fitting the eligibility criteria will be identified by the treating physicians who are investigators in this study. The treating physicians will introduce the patients to the study. Interested patients will be referred to principal investigator who will provide further study information to patients including procedures and risks of study imaging scans. The patients will be given ample time to completely read the informed consent form and ask any questions. The patients will be contacted by the principal investigator with regards to their decision in partaking in the study. Patients that agree to partake in the study will be asked to sign an informed consent form at their next hospital visit.
The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents. Patients who agree to participate will be contacted by principal investigator to organize times for to the study scans to be conducted.

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



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2013
Actual
2/08/2013
Date of last participant enrolment
Anticipated
Actual
12/12/2014
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
30
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285119 0
University
Name [1] 285119 0
University of Sydney
Country [1] 285119 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Radiation Physics Laboratory- Sydney Medical School
Room 475, Blackburn Building D06
Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 283975 0
Hospital
Name [1] 283975 0
Royal North Shore Hospital
Address [1] 283975 0
Department of Radiation Oncology,
St Leanards, NSW, 2065
Country [1] 283975 0
Australia
Other collaborator category [1] 260746 0
University
Name [1] 260746 0
Stanford Cancer Center
Address [1] 260746 0
Radiation Physics Division
Department of Radiation Oncology
Stanford Cancer Center
1501 S California Ave, Rm 2415
Palo Alto
94304-1110
USA
Country [1] 260746 0
United States of America
Other collaborator category [2] 260747 0
Commercial sector/Industry
Name [2] 260747 0
Philips Research Europe Hamburg
Address [2] 260747 0
Department of Digital Imaging
Rontgenstrasse 24-26
Hamburg
22335
Germany
Country [2] 260747 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287135 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 287135 0
Ethics committee country [1] 287135 0
Australia
Date submitted for ethics approval [1] 287135 0
18/05/2012
Approval date [1] 287135 0
21/01/2013
Ethics approval number [1] 287135 0
1206-175M

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

Contacts
Principal investigator
Name 34076 0
Dr Enid Eslick
Address 34076 0
The University of Sydney
Radiation Physics Laboratory - Sydney Medical School Rm 475, Blackburn Building, D06 Camperdown, NSW, 2006
Country 34076 0
Australia
Phone 34076 0
+61 478 403 572
Fax 34076 0
+61 2 9351 4018
Email 34076 0
enid.eslick@sydney.edu.au
Contact person for public queries
Name 17323 0
Shona Silvester
Address 17323 0
Image X Institute - University of Sydney
Suite 201, Level 2, Biomedical Building
1 Central Avenue
Eveleigh NSW 2015
Country 17323 0
Australia
Phone 17323 0
+61 2 8627 1185
Fax 17323 0
Email 17323 0
shona.silvester@sydney.edu.au
Contact person for scientific queries
Name 8251 0
Enid Eslick
Address 8251 0
Radiation Physics Laboratory - Sydney Medical School
Rm 475, Blackburn Building, D06
Camperdown, NSW, 2006
Country 8251 0
Australia
Phone 8251 0
+61 478 403572
Fax 8251 0
Email 8251 0
enid.eslick@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant imaging data collected during the trial
When will data be available (start and end dates)?
Available from 2016 onwards. No end date has been determined.
Available to whom?
Collaborators
Available for what types of analyses?
CT ventilation studies
How or where can data be obtained?
by contacting Image X Institute Director, Prof Paul Keall. Paul.Keall@sydney.edu.au


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
SourceTitleYear of PublicationDOI
Dimensions AIMeasurement of preoperative lobar lung function with computed tomography ventilation imaging: progress towards rapid stratification of lung cancer lobectomy patients with abnormal lung function2015https://doi.org/10.1093/ejcts/ezv276
EmbaseCT ventilation imaging derived from breath hold CT exhibits good regional accuracy with Galligas PET.2018https://dx.doi.org/10.1016/j.radonc.2017.12.010
N.B. These documents automatically identified may not have been verified by the study sponsor.