We partner with leading health providers in NSW and across the world to conduct clinical trials that translate our research in to solutions that directly improve the lives of patients. Clinical trials are the key to the development of safe, effective health technology.
Current Clinical Trials
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REACT: Respiratory Adaptive Computed Tomography
A Pilot Feasibility Study on the Use of Real-Time Gated 4DCT for Lung Cancer Radiation Therapy
The primary objective of the study is to investigate the feasibility of acquiring Real-Time Gated 4DCT scans for lung cancer patients undergoing radiation therapy and to determine the incidence of imaging artefacts in comparison to conventional 4DCT.
Trial information page: https://clinicaltrials.gov/study/NCT05030207? titles=REACT:%20Respiratory%20Adaptive%20Computed%20Tomography&rank=1
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ROCK-RT: Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
Radio-opaque contrast agents for liver cancer targeting
This observational study will investigate the properties of image files standardly collected during radiation therapy treatment in a cross-section of liver cancer patients who received stereotactic ablative body radiation therapy (SABR) after trans-catheter arterial chemo emobilisation (TACE). Specifically, it will determine whether the radio-opaque contrast agents in the image files can be detected by tumour-tracking software (KIM).
Protocol paper: https://pmc.ncbi.nlm.nih.gov/articles/PMC11462695/
Trial information: https://clinicaltrials.gov/study/NCT05169177
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VENTURE: Ventilation using radiographic examination
A pilot study to compare functional lung imaging techniques for the reduction of toxicity in functional avoidance radiotherapy
The goal of this observational validation study is to determine the best implementation of fluoroscopic and CT ventilation imaging in patients having non-stereotactic ablative body radiotherapy (non-SABR) radiotherapy for stages II-IV lung cancer. The main questions it aims to answer are:
- Assess the dosimetric variation in functional avoidance radiation therapy (RT) plans produced using these ventilation imaging techniques,
- Establish a quality assurance procedure for functional lung avoidance radiation therapy, and
- Evaluate the clinical acceptable thresholds for accuracy of the method.
Trial information: https://clinicaltrials.gov/study/NCT06159660
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Real-Time IGRT: a Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
A master trial assessing the technical feasibility of first-in-human real-time image guided radiation therapy methods
The goal of this clinical trial is to determine whether Real-Time Image Guided Radiation Therapy is a feasible method for radiation therapy delivery for patients with cancer.
The main questions it aims to answer are:
Are there any unexpected grade >3 acute toxicities?
Can all fractions per patient which are intended to be delivered with the real-time IGRT method be completed as planned?
Can the beam accurately hit the tumour in ≥85% of fractions?
Trial information page: https://clinicaltrials.gov/study/NCT06708221
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POPPY: Post-Operative Prediction of PulmonarY function
A pilot study to assess the benefit of incorporating regional ventilation information in the prediction of post-operative lung function for lung cancer surgery.
Trial size: 15
Trial site: Royal North Shore Hospital
Trial information page: https://clinicaltrials.gov/study/NCT06494254
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VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy
Improving quality of life for patients with lung cancer treated with radiation therapy.
This trial is testing a new treatment planning method for patients with lung cancer who will be treated with radiation therapy. This new method is called Computed Tomography (CT) ventilation imaging. It aims to help protect the healthiest parts of patient’s lungs from being injured by the radiation therapy. The investigators will determine whether healthy lung sparing can improve the quality of life in these patients.
Trial size: 165
Trial information page: https://clinicaltrials.gov/study/NCT06127654
Participant information page: The VITaL Clinical Trial
Technology / project page: CT Ventilation Imaging
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MANGO: Magnetic resonance imaging of hypoxia for radiation treatment guidance in glioblastoma multiforme
Using imaging biomarkers of hypoxia to improve diagnostic and prognostics in GBM management.
This study is designed to evaluate the role of Oxygen Enhanced (OE) Magnetic resonance imaging (MRI) and Blood Oxygenation Level Dependent (BOLD) MRI in detecting regions of hypoxic tumour and to evaluate their use as imaging methods to selectively deliver targeted radiotherapy to regions of aggressive disease.
Trial information page: https://clinicaltrials.gov/study/NCT05500612
Trial protocol paper: https://pubmed.ncbi.nlm.nih.gov/38192626/
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MAGIK: Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
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. The goal is to determine wether Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy.
Study size: 30 patients
Study Site: The Alfred HospitalStudy Protocol publication: https://pubmed.ncbi.nlm.nih.gov/35058267/
More information: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=22164&isClinicalTrial=True
Completed Clinical Trials
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CHIRP: Collection of Head Images during Radiotherapy
The primary objective of this observational study is to quantify the translation, rotation, and deformation of patient head positions of head and neck cancer patients over the course of a radiation therapy treatment for head and neck cancer. This objective will be achieved by comparing X-ray images collected during each treatment session with those obtained from the planning CT scan. Secondary objectives include (1) the use of the collected X-ray images to develop realistic artificial X-ray images where patient movement can be simulated and (2) to determine whether motion can be detected from individual X-ray images acquired during radiation therapy treatment.
Trial information: https://clinicaltrials.gov/study/NCT05218824
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LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Improving new radiation therapy techniques for treating liver cancer.
The LARK trial looks at treatment outcomes and treatment efficiency when incorporating our KIM technology with SABR, a new and effective radiation therapy technique that is becoming widely used.
KIM technology provides the radiation therapist with real-time information about the exact location of the tumour. This trial will determine how effectively KIM helps the radiation therapist deliver a more accurate radiation dose. Participants have fiducial markers inserted around their tumours to allow the KIM system to track tumour movement as the patient breathes.
Sites: Westmead Hospital, Nepean Hospital, Princess Alexandra Hospital
Study Protocol: https://pubmed.ncbi.nlm.nih.gov/33941111/
Trial info: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=18258&isClinicalTrial=True
Technology: Kilovoltage Intrafraction Monitoring (KIM)
Collaborating Group: TROG Cancer Research
More information: Available at the Australia and New Zealand Clinical Trials Registry here.
Results Paper: https://www.sciencedirect.com/science/article/pii/S0167814023093386
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BRAVEHeart: Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Saving the heart from damage during breast cancer radiation therapy.
We have developed a device to help patients manage Deep Inspiration Breath Hold (DIBH) – 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 the chance of the heart tissue being damaged during radiation treatment. The BRAVEHeart trial uses 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.
Site: Royal North Shore Hospital
Protocol paper: https://link.springer.com/article/10.1186/s13063-023-07072-y
Trial outcomes paper https://www.advancesradonc.org/article/S2452-1094(24)00135-0/fulltext
Technology: AV Biofeedback
More information: Available at the Australia and New Zealand Clinical Trials Registry here.
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Nano-X: Patient Experience and Acceptance of Horizontal Rotation
Measuring the patient’s experience 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 rotating the patient rather than rotating the enormous weight of the radiation therapy gantry. The NanoX is designed to be a low-cost radiotherapy system to allow for rural areas and developing countries to be able to access high quality cancer treatment.
This would 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. We are collecting feedback from patient volunteers to determine whether rotation is an acceptable experience.
Site: Prince of Wales Hospital
Technology: Nano-X
More information: Available at the Australia and New Zealand Clinical Trials Registry here.
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AVIATOR: Audio-Visual Investigation Advancing Thoracic Radiotherapy.
Accurate Treatment for Lung Tumours
Lungs tumours are difficult to treat with a static radiation beam because they’re in constant motion as the patient breathes. We’re trialing technology developed by our researchers that uses real-time information about the patient’s breath to indicate the tumour location.
The technology monitors the motion of the chest rising and falling, and coaches the patient to have steady breath and breath-holds which put the tumour in the right position for treatment. This helps the radiation therapist to hit the tumour with radiation even more accurately. The technology has already been successfully trialed for breast cancer patients. In this study, we’ll determine whether our technology will offer the same treatment improvements for people with lung cancer.
This is the largest study of its kind to date, performed across 7 radiation oncology departments and 75 patients across NSW and ACT.
Sites: Westmead Hospital, Canberra Hospital and Calvary Mater Hospital
Technology: AV Biofeedback
More information: Available at the Australia and New Zealand Clinical Trials Registry here.
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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 [email protected] -
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.
Study size: 20 Stage I NSCLC patients
Site: Royal North Shore Hospital -
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.
Study size: 30 patients
Sites: Liverpool Hospital, Macarthur Hospital
Collaborating Group: TROG Cancer Research -
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 [email protected] -
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: [email protected] -
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 [email protected]