Clinical translational trials

Clinical-translational trials are a fundamental focus of our group. In these studies, we aim to transition scientific research into clinical practice where it can be of direct benefit to patients.

Ongoing clinical translational trials |
Upcoming clinical translational trials |
Completed clinical translational trials

Ongoing clinical translational trials

SPARK: Stereotactic Prostate Adaptive Radiotherapy utilising Kilovoltage intrafraction monitoring

Prostate motion during radiotherapy treatment delivery may shift the tumour outside the beam, simultaneously reducing target dose and exposing normal tissues to potentially damaging radiation doses.SPARK seeks to validate the use of Kilovoltage Intrafraction Monitoring (KIM) to manage intrafraction motion in the Stereotactic Body Radiotherapy (SBRT) treatment of low to intermediate risk cases of prostate cancer.SPARK is a phase II multicentre, single armed, two stage study that will measure cancer targeting accuracy and patient outcomes in 48 prostate cancer patients treated with a novel cost effective real-time targeting radiotherapy technology developed and pioneered in Australia.

Project status: 28 patients recruited
Study size: 48 prostate cancer patients
Site: Multi site
Collaborating group: TROG Cancer Research
Contact: Doan Trang Nguyen. E: d.nguyen@sydney.edu.au
Kilovoltage Intrafraction Monitoring

LAVA: Liver cancer Audio-Visual biofeedback Assessment

Project description: This investigation aims to test whether the more regular respiration as provided by AV biofeedback will result in more reproducible liver tumour motion which is expected to have numerous clinical advantages. This study will involve the recruitment of 30 liver cancer patients undergoing SBRT. SBRT involves a very high radiation dose to the target area so accurate targeting and tight treatment margins are an absolute must to minimize the risk to the surrounding healthy tissue, especially for a region as radiosensitive as the liver. This study will investigate the motion of fiducial markers planted about the liver tumour and assess the corresponding potential clinical benefit of AV biofeedback (improved image quality, treatment margins, and dose distributions).

Project status: 5 patients recruited
Study size: 30 liver cancer patients
Site: Chris O’Brien Lifehouse, Department of Radiation Oncology
Contact: Elisabeth Steiner. E: elisabeth.steiner@sydney.edu.au
Audiovisual biofeedback

LAVA

Left: LAVA patient study setup. Middle: Example CBCT image with fiducial marker circled. Right:: Fiducial marker motion

AVIATOR: Audio-Visual Investigation Advancing Thoracic Radiotherapy

Project description: This investigation will involve a technological assessment of the AV biofeedback system in a clinical setting. Such an investigation will involve an assessment of patient and technician experience with AV biofeedback, looking at patient benefits, impact on image quality and treatment margins. This study will be performed across 7 radiation oncology departments across NSW and ACT, promoting the widespread clinical implementation of AV biofeedback. Performing this investigation across 7 departments will also allow for larger sample size: a total of 75 lung cancer patients. AVIATOR will be the largest study of its kind to date.

Project status: This study is underway at Calvary Mater Hospital with 10 patients recruited. Further sites are planned.
Study size: 75 lung cancer patients
Sites: Royal North Shore Hospital, Westmead Hospital, Chris O’Brien Lifehouse, Nepean Hospital, Canberra Hospital, Calvary Mater Hospital, and Gosford Hospital
Contact: Elisabeth Steiner. E: elisabeth.steiner@sydney.edu.au
Audiovisual biofeedback

AVIATOR

The AV biofeedback system to be implemented in both the treatment (left) and imaging (right) rooms in addition to the options of utilising either goggles (left) or tablet-computer (right) as the AV biofeedback display. Such applicability in different settings in addition to its compatibility with a range of display options makes AV biofeedback suitable to the range of facility equipment across multiple departments.

Upcoming clinical translational trials

Deep Inspiration Breath Hold and BRAVEHeart

Deep Inspiration Breath Hold (DIBH) is a technique where patients take a deep breath and hold it while radiation therapy is being delivered. Filling the lungs with air increases the distance between the target of radiation therapy (a lung or breast tumour) and the heart. This reduces that chance of the heart tissue being damaged during radiation treatment. The BRAVEHeart trial utilises an audiovisual feedback device (Breathe Well) to assist the patient in controlling their breathing pattern and it will be tested in patients undergoing treatment for breast cancer.

Project status: Study proposal approved at RNSH. Further sites are planned.
Study size: 40 breast cancer patients
Sites: Royal North Shore Hospital
Contact: Elisabeth Steiner. E: elisabeth.steiner@sydney.edu.au
Audiovisual biofeedback

Completed clinical translational trials

AVATAR: Audio-Visual Assessment of ThorAcic Respiration

Project description: This study will test an MRI-AV biofeedback system to investigate its impact on tumour motion reproducibility. This study will be performed across 4 stages, recruiting 15 lung cancer patients at each stage; the purpose of dividing the study into 4 stages is to monitor the development of the MRI-AV biofeedback system towards real-time 3D tumour motion monitoring and guidance. The 4 stages of this study will investigate the MRI-AV biofeedback system using the respiratory signal from:
(1) the real-time abdominal motion utilising the RPM system,
(2) the 1D tumour motion extracted from MR images,
(3) the 2D tumour motion extracted from MR images,
(4) the 3D tumour motion extracted from MR images.
This study will also further develop MRI reconstruction methods towards improved image quality and real-time image acquisition and tumour delineation.

Project status: Five lung cancer patients have been recruited in the first stage of the study.
Study size: 60 lung cancer patients.
Sites: Calvary Mater Newcastle Hospital, Department of Radiation Oncology
Contact: Danny Lee. E: danny.lee@sydney.edu.au
Audiovisual biofeedback

MRI_AV

Left: MR images demonstrating the breathing motion of lung tumours under free breathing (top) and AV biofeedback (bottom) breathing conditions


An Investigation of CT ventilation as a functional imaging modality for lung cancer radiotherapy

Project description: This study investigated the use of four-dimensional computed tomography imaging in providing accurate ventilation imaging for lung cancer radiotherapy planning. Incorporating lung functional imaging, such as ventilation, enables the differentiation of normal functioning lung tissue and diseased lung. This can be used to optimise treatment planning to minimise lung toxicity and improve treatment outcomes for lung cancer patients. CT ventilation imaging was validated against nuclear medicine ventilation imaging. The results of this trial were published in the European Journal of Cardio-Thoracic Surgery.

Protocol No: ACTRN12612000775819
Study size: 20 lung cancer patients treated with RT
Site: Department of Radiation Oncology and Nuclear Medicine at the Royal North Shore Hospital
Contact: Enid Eslick , enid.eslick@sydney.edu.au
CT-based ventilation imaging


An investigation into the patient experience of single, slow rotation in the upright and lying positions

Project description: This project will provide the first quantitative data on patient response to slow rotation in both the lying and upright positions. To do this we will use existing TGA approved medical equipment (The Epley Omniax ) from the field of balance disorder therapy to slowly rotate patients. Validated psychometric questionaries will be used to assess whether any noticeable increase in patient anxiety levels or motion sickness occurs.

If patient rotation is shown to be a feasible in radiotherapy, it will vastly simplify the engineering challenges associated with delivery of radiotherapy. This is particularly true for advanced new treatment options such as MRI guided radiotherapy , Proton Therapy and Heavy Ion Therapy. Patient rotation would mean that these advanced techniques could be made accessible to a far wider population than the limited few who can currently benefit from them. To date, patient response to slow rotation has not been tested.

Ethics: RPAH Ethics Review Committee, Protocol Number X12-0390
Study Size: 15
Site: Royal Prince Alfred Hospital
Contact: Brendan Whelan, brendan.whelan@sydney.edu.au


In-situ MRI guided audiovisual biofeedback for precise lung cancer radiotherapy

Project description: Lung cancer is the most common cancer related cause of death. Many patients rely on radiotherapy treatment as part of their disease management. However, the precision of radiotherapy is affected by involuntary movements such as respiratory motion, which results in poor targeting and therefore, poor tumour control. In this project an audiovisual (AV) biofeedback respiratory motion management system will be developed using the Real-time Position Management (RPM, Varian) device. This system utilizes an external marker to track a patient's breathing motion and uses visual cues such as a trace, and audio cues to help the patient to keep to regular breathing motion. Concurrent MRI will be acquired which will allow the study of the motion correlation between an internal breathing surrogate (e.g. the diaphragm) and the real-time external marker. The reproducibility of breathing motion will be studied with and without the use of AV biofeedback.

Protocol No: 05-2011 / 13778
Study size: 15 healthy volunteers
Site: Brain and Mind Research Institute (BMRI)
Contact: Dr. Taeho Kim, taeho.kim@sydney.edu.au
Audiovisual biofeedback

Taeho_AV_MRI

Examples of Free Breathing and AV biofeedback breathing traces obtained from the MR images.


Kilovoltage Intrafraction Monitoring: A Novel Real-time Tumour Localization Modality

Project description: Prostate tumours move during radiotherapy treatment. This results in reduced geometric and dosimetric accuracy. Typically this motion is not observed during treatment. Several real-time tumour localization modalities exist i.e. ultrasound, magnetic resonance imaging (MRI), optical, MV, combined MV/kV, Calypso electromagnetic guidance and the Navotek radioactive fiducial implant. However, some of these are under development, not easily available or expensive. An ideal solution would be to use existing linear accelerator (linac) systems. Kilovoltage intrafraction monitoring is a novel intrafraction real-time tumour localization method. It involves a single gantry-mounted kV x-ray imager (widely available on most linacs) acquiring 2D projections of implanted fiducial markers. 3D positions are then reconstructed by maximum likelihood estimation of a 3D probability density function. Recently, this novel modality has been clinically implement for the first time for patients with localized prostate cancer undergoing intensity modulated arc therapy (IMAT).

Protocol No: 1106-196M
Study size: 10 prostate cancer patients
Site: Northern Sydney Cancer Centre, Royal North Shore Hospital, St Leonards
Contact: Jin Aun, NG , jin.aun@sydney.edu.au
Kilovoltage intrafraction monitoring