Clinical trials
AVIATOR: Audio-Visual Investigation Advancing Thoracic Radiotherapy
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: The study is underway at with 19 patients recruited.
Study size: 75 lung cancer patients
Sites: Calvary Mater Newcastle, Canberra Hospital and Westmead Hospital
Contact: Youssef Ben Bouchta youssef.benbouchta@sydney.edu.au
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: 28 patients recruited. Open to recruitment.
Study size: 40 breast cancer patients
Site: Royal North Shore Hospital
Contact: Youssef Ben Bouchta youssef.benbouchta@sydney.edu.au
Nano-X – Patient experience and acceptance of horizontal rotation
Nano-X is a new radiotherapy machine designed and built in Sydney, consisting of a patient rotation system together with a radiotherapy system. Nano-X proposes to utilise patient rotation to substantially decrease the cost and size of conventional radiotherapy machines. In this trial, we will use the Nano-X patient rotation system only, without the radiotherapy system, to rotate patient volunteers to determine their level of acceptance.
Project status: Open to recruitment.
Study size: 100 patients
Site: Prince of Wales Hospital
Contact:Paul Liu: Paul.Liu@sydney.edu.au
LARK – Liver Ablative Radiotherapy utilising Kilovoltage Intrafraction Monitoring
The LARK trial will look at treatment outcomes and treatment efficiency when incorporating KIM with SABR to treat eligible patients with primary or secondary liver cancer. Participants will have fiducial markers inserted around their tumours to allow the KIM system to track tumour movement as the patient breathes.
Project status: Open to recruitment.
Study size: 46 patients
Sites: Westmead Hospital, Nepean Hospital, Princess Alexandra Hospital.
Collaborating Group: TROG Cancer Research
Contact: Doan Trang Nguyen d.nguyen@sydney.edu.au
Recently Completed
ADAPT – Adaptive CT acquisition for personalised thoracic imaging
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 we are able to acquire personalised images of a patients lungs for radiotherapy treatments.
Project status: Recruitment Complete
Study size: 30 patients
Sites: Liverpool Hospital, Macarthur Hospital
Collaborating Group: TROG Cancer Research
Contact: Ricky O’Brien ricky.obrien@sydney.edu.au
LIGHT-SABR – Phase I Feasibility study of Lung Cancer Radiotherapy using Real-time Dynamic Multileaf Collimator Adaptation and Radiofrequency Tracking
In this investigation, patients being treated with Stereotactic Body Radiotherapy (SBRT) for lung cancer will receive a new treatment. Beacons will be implanted into the patients’ lung to allow Multi Leaf Collimator (MLC) tracking equipment to precisely follow the movement of the lung. The difference between tracking tumour movement with MLC versus the current standard method will be compared to identify any variances. Audio-visual (AV) Biofeedback will also be used to regulate patients’ breathing during radiotherapy.
Project status: Now closed to recruitment. 17 patients accrued. Participants now in follow up and analysis has begun.
Study size: 20 Stage I NSCLC patients
Site: Royal North Shore Hospital
Contact: Vincent Caillet vcai6204@uni.sydney.edu.au
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: Results have now been published. Now closed to recruitment. Reached full accrual of 48 patients in March 2018.
Study size: 48 prostate cancer patients
Site: Multi-site
Collaborating group: TROG Cancer Research
Contact: Doan Trang Nguyen d.nguyen@sydney.edu.au
Opening Soon
MAGIK
This trial will use implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging. It is a Phase I Interventional Study of Lung Cancer Radiotherapy
Project status: Opening soon.
Study size: 30 patients
Sites: The Alfred Hospital
Contact: Marco Mueller marco.mueller@sydney.edu.au
Nano-X Image Guidance
In this trial, we will use the Nano-X patient rotation system with the radiotherapy system, to rotate patients whilst imaging them.
Project status: Opening soon.
Study size: 30 patients
Sites: Prince of Wales Hospital
Contact: Paul Liu paul.liu@sydney.edu.au
SMART
We have developed a mask-free system to remove the need for a thermoplastic immobilisation mask for patients being treated with radiotherapy for Head and Neck Cancer. This trial will look at the technical feasibility of our surface monitoring technology, as well as patient acceptance of the mask-free system. Our surface monitoring technology has been specifically designed to accurately collect data about location and movement, and reduce anxiety and discomfort in participants.
Project status: Opening soon.
Study size: 20 patients
Sites: Blacktown Hospital
Contact: Youssef Ben Bouchta youssef.benbouchta@sydney.edu.au