ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Intervention code [2]

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]

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]

Within 2 weeks of initial consultation from medical specialist (Respiratory Physicians or Radiation Oncologists) at Royal North Shore Hospital.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Address [1]

Radiation Physics Laboratory- Sydney Medical School
Room 475, Blackburn Building D06
Camperdown, NSW, 2006

Country [1]

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]

Hospital

Name [1]

Royal North Shore Hospital

Address [1]

Department of Radiation Oncology,
St Leanards, NSW, 2065

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Stanford Cancer Center

Address [1]

Radiation Physics Division
Department of Radiation Oncology
Stanford Cancer Center
1501 S California Ave, Rm 2415
Palo Alto
94304-1110
USA

Country [1]

United States of America

Other collaborator category [2]

Commercial sector/Industry

Name [2]

Philips Research Europe Hamburg

Address [2]

Department of Digital Imaging
Rontgenstrasse 24-26
Hamburg
22335
Germany

Country [2]

Germany

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Health Human Research Ethics Committee

Ethics committee address [1]

The Research Office, Level 13, Kolling Building 
Royal North Shore Hospital, Pacific Hwy
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/05/2012

Approval date [1]

21/01/2013

Ethics approval number [1]

1206-175M

Summary

Brief summary

This study looks at whether we can obtain information about lung function (showing us areas of lung that work well and areas that do not) from a type of computed tomography scan (CT scan) known as four dimension computed tomography scan (4D-CT scan). Unlike other types of CT scans, 4D-CT scans have the potential to provide lung function information as well as the usual anatomical information. It is hoped that we can then include this lung function information in the planning of radiotherapy treatment to reduce the chances of irradiating the functioning lung areas. This has the potential to minimise side-effects. 

4D-CT scans are mainly used for early stage lung cancer patients where it provides highly accurate anatomical information, however, we are testing its use in providing additional information, lung function information, for all stages of lung cancer. If this study shows that 4D-CT scans can provide accurate lung function information, it will be used for the treatment planning of all stages of lung cancer which will allow better treatment delivery and hopefully better treatment outcomes.

Who is it for?

You may be eligible for this study if you are 18 and over and have been diagnosed with lung cancer and scheduled or not scheduled for treatment with radiotherapy. Further inclusion details for this trial can be found in the Inclusion Criteria section of this form. 

Trial details

This is a 30 lung cancer patient clinical imaging study in assessing the accuracy of a new type of imaging data from computed tomography (CT) known as CT ventilation imaging. Patients will undergo CT scans, data from which will be used to create a ventilation image which will be compared to their ventilation image acquired from a nuclear medicine scan, considered to be the 'gold standard'. If CT ventilation imaging is found to be physiologically accurate, its great advantage lies in its easy implementation in radiotherapy planning to minimise radiation induced lung toxicity.

Trial website

http://sydney.edu.au/medicine/radiation-physics/research-projects/CT-ventilation-imaging.php

Trial related presentations / publications

T. Yamamoto, S. Kabus, J. von Berg, C. Lorenz and P. J. Keall, "Impact of four-dimensional computed tomography pulmonary ventilation imaging-based functional avoidance for lung cancer radiotherapy" Int. J. Radiat. Oncol. Biol. Phys. 79, 279-288 (2010).

T. Y. T. Yamamoto, S. Kabus, T. Klinder, C. Lorenz, J. von Berg, T. Blaffert, B. W. Loo and P. J. Keall, "Investigation of four-dimensional computed tomography-based pulmonary ventilation imaging in patients with emphysematous lung regions," Phys. Med. Biol. 56, 2279-2298 (2011).

Public notes

Contacts

Principal investigator

Name

Dr Enid Eslick

Address

The University of Sydney
Radiation Physics Laboratory - Sydney Medical School Rm 475, Blackburn Building, D06 Camperdown, NSW, 2006

Country

Australia

Phone

+61 478 403 572

Fax

+61 2 9351 4018

enid.eslick@sydney.edu.au

Contact person for public queries

Name

Shona Silvester

Address

Image X Institute - University of Sydney
Suite 201, Level 2, Biomedical Building
1 Central Avenue
Eveleigh NSW 2015

Country

Australia

Phone

+61 2 8627 1185

Fax

shona.silvester@sydney.edu.au

Contact person for scientific queries

Name

Enid Eslick

Address

Radiation Physics Laboratory - Sydney Medical School
Rm 475, Blackburn Building, D06
Camperdown, NSW, 2006

Country

Australia

Phone

+61 478 403572

Fax

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

Source	Title	Year of Publication	DOI
Dimensions AI	Measurement of preoperative lobar lung function with computed tomography ventilation imaging: progress towards rapid stratification of lung cancer lobectomy patients with abnormal lung function	2015	https://doi.org/10.1093/ejcts/ezv276
Embase	CT ventilation imaging derived from breath hold CT exhibits good regional accuracy with Galligas PET.	2018	https://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.

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Documents added manually

Documents added automatically