CancerReal-Time IGRTNCT06708221
A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
A study testing Real-Time Image Guided Radio Therapy (IGRT) in people with Cancer, run by University of Sydney at 1 site in Australia.
Trial summary
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: Can all fractions per patient which are intended to be delivered with the real-time IGRT method be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Real-Time Image Guided Radio Therapy (IGRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2027to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older to be treated with curative radiation therapy
- Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer
- ECOG performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Pregnancy,
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation
- Additional inclusion and exclusion criteria may apply to a specific sub-study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Nick Hardcastle, +61 (03) 8559 6940, nick.hardcastle@petermac.org
Shankar Siva
About this study
Official title: Real-Time IGRT: 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:
- 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?
- Are there any unexpected grade >3 acute toxicities?
Participants will not require any additional treatments or preparation procedures above those required for normal radiation therapy treatment, to participate in this study.
Read the detailed description
Real-time IGRT is a master trial to assess the technical feasibility of first-in-human real-time image guided radiation therapy methods.
Real-time image guided radiation therapy (IGRT) methods image the cancerous tumour in real-time, enabling the treatment beam to focus its destructive energy on the patient's cancer, not their healthy tissue. Using a real-time IGRT method available on scarce $10M MRI-guided radiation therapy devices, has halved the incidence of acute grade 2 or greater genitourinary (GU) toxicity for prostate cancer patients. However, >95% of radiotherapy is given on standard $3M devices. The halving in GU toxicity was confirmed in a study from Memorial Sloan-Kettering using combined kilovoltage and megavoltage guidance. This clinical benefit has led to a global demand: over 70% of centres want better real-time IGRT methods but are limited by resources and capacity. The tipping point is the implementation of real-time IGRT methods on standard devices. The Real-time IGRT trial addresses this unmet need by assessing an array of real-time IGRT methods.
To establish real-time IGRT methods, the University of Sydney partner hospitals and cancer centres have been working together across many different cancers, to create a database of images that have been, and are being, used to develop real-time IGRT methods. This development has led to the creation of LEARN, the Learning Environment for Artificial Intelligence in Radiotherapy New Technology, and the associated image acquisition study (https://clinicaltrials.gov/study/NCT05184790). The LEARN study looks at images retrospectively, meaning patients do not directly benefit from their involvement. To achieve benefit for study patients, and ultimately in broader practice, prospective implementation of real-time IGRT methods is required. This umbrella protocol, Real-time IGRT, enables a framework for the safe implementation and evaluation of real-time IGRT methods. Patient dosimetric and geometric targeting benefits will be measured, with the information acquired used to further improve the safety and accuracy of real-time IGRT methods.
The technologies being developed are numerous, covering different individual and combinations of imaging methods (surface, kV, MV), are applicable to different cancer sites, use marker and markerless approaches, and track one or more targets and normal tissues. To perform a feasibility study for each single innovation and for each single tumour site is time consuming when using a standard trial protocol. Instead, a master protocol trial comprises one general protocol that includes multiple subgroups and/or multiple interventions. Given this large variety of methods to be tested, a master protocol trial is the most efficient to maximise the safe testing of technologies, and to cease or pause technologies that do not meet the clinical requirements.
The master protocol trial aims to increase efficiency in terms of trial infrastructure and protocol administration to accelerate development of technical innovations in radiation oncology, meaning that patients benefit from the technologies earlier. By including multiple parallel cohorts, the protocol will accelerate the technical development of real-time IGRT methods and the evidenced-based introduction of real-time IGRT methods into clinical practice. This approach reduces the burden on the HREC, the sponsor and the participating centres.
- Conditions
- Cancer
- Being tested
- Real-Time Image Guided Radio Therapy (IGRT)
- Keywords
- cancer, IGRT, radiotherapy, radiation therapy, Image Guided Radiation Therapy, breast cancer, lung cancer, Australia
- Medical subject headings
- Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Image Guided Radio Therapy (IGRT)Device
Real-time image guided radiation therapy (IGRT) methods image the cancerous tumour in real-time, enabling the treatment beam to focus its destructive energy on the patient's cancer, not their healthy tissue.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time IGRT | Experimental | Real-Time IGRT Receives: Device: Real-Time Image Guided Radio Therapy (IGRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful application of Real-Time IGRT
Each real-time IGRT method under study is deemed feasible if successfully applied in 18 out of 20 consecutive patients (success rate of 90%), with a maximum of 40 patients to be included per cohort. If the real-time IGRT method is unsuccessfully applied in three consecutive patients or the real-time IGRT method is not successfully applied in 18 out of 20 consecutive patients after the inclusion of 40 patients, it is considered unfeasible. For each real-time IGRT method, success is defined by three general criteria (each of the three criteria should be met to reach feasibility):
- All fractions per patient which are intended to be delivered with the real-time IGRT method are completed as planned
- Absence of geographical miss in ≥85% of fractions or, in case of stereotactic treatments, in all minus one fraction. Geographical miss is defined as the clinical treatment volume outside the treated volume as measured on post-treatment image analysis
- No unexpected grade >3 acute toxicities
Measured: From the date of enrolment until 90 days after the completion of radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study startJun 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Future Fund
- Responsible party
- Sponsor
- Investigators
- Paul Keall, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708221
- Sponsor's protocol ID
- RealTimeIGRT
- Acronym
- Real-Time IGRT
- Status last verified
- May 2026
- First submitted
- 13 Nov 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aligned with the NHMRC's Open Access Policy and the Health Studies Australian National Data Asset (HeSANDA) program, the Real-Time IGRT trial will aim to make the de-identified trial data publicly available for other scientific research via an external research data repository, archive or register. E.g. The Cancer Imaging Archives (TCIA, https://www.cancerimagingarchive.net/). Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time IGRT: A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
- ClinicalTrials.gov ID
- NCT06708221
- Acronym / sponsor ID
- Real-Time IGRT / RealTimeIGRT
- Conditions
- Cancer
- Keywords
- cancer, IGRT, radiotherapy, radiation therapy, Image Guided Radiation Therapy, breast cancer, lung cancer, Australia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Medical Research Future Fund
- Study start
- Jun 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Are there any unexpected grade >3 acute toxicities?
Participants will not require any additional treatments or preparation procedures above those required for normal radiation therapy treatment, to participate in this study.
Detailed description
Real-time IGRT is a master trial to assess the technical feasibility of first-in-human real-time image guided radiation therapy methods.
Real-time image guided radiation therapy (IGRT) methods image the cancerous tumour in real-time, enabling the treatment beam to focus its destructive energy on the patient's cancer, not their healthy tissue. Using a real-time IGRT method available on scarce $10M MRI-guided radiation therapy devices, has halved the incidence of acute grade 2 or greater genitourinary (GU) toxicity for prostate cancer patients. However, >95% of radiotherapy is given on standard $3M devices. The halving in GU toxicity was confirmed in a study from Memorial Sloan-Kettering using combined kilovoltage and megavoltage guidance. This clinical benefit has led to a global demand: over 70% of centres want better real-time IGRT methods but are limited by resources and capacity. The tipping point is the implementation of real-time IGRT methods on standard devices. The Real-time IGRT trial addresses this unmet need by assessing an array of real-time IGRT methods.
To establish real-time IGRT methods, the University of Sydney partner hospitals and cancer centres have been working together across many different cancers, to create a database of images that have been, and are being, used to develop real-time IGRT methods. This development has led to the creation of LEARN, the Learning Environment for Artificial Intelligence in Radiotherapy New Technology, and the associated image acquisition study (https://clinicaltrials.gov/study/NCT05184790). The LEARN study looks at images retrospectively, meaning patients do not directly benefit from their involvement. To achieve benefit for study patients, and ultimately in broader practice, prospective implementation of real-time IGRT methods is required. This umbrella protocol, Real-time IGRT, enables a framework for the safe implementation and evaluation of real-time IGRT methods. Patient dosimetric and geometric targeting benefits will be measured, with the information acquired used to further improve the safety and accuracy of real-time IGRT methods.
The technologies being developed are numerous, covering different individual and combinations of imaging methods (surface, kV, MV), are applicable to different cancer sites, use marker and markerless approaches, and track one or more targets and normal tissues. To perform a feasibility study for each single innovation and for each single tumour site is time consuming when using a standard trial protocol. Instead, a master protocol trial comprises one general protocol that includes multiple subgroups and/or multiple interventions. Given this large variety of methods to be tested, a master protocol trial is the most efficient to maximise the safe testing of technologies, and to cease or pause technologies that do not meet the clinical requirements.
The master protocol trial aims to increase efficiency in terms of trial infrastructure and protocol administration to accelerate development of technical innovations in radiation oncology, meaning that patients benefit from the technologies earlier. By including multiple parallel cohorts, the protocol will accelerate the technical development of real-time IGRT methods and the evidenced-based introduction of real-time IGRT methods into clinical practice. This approach reduces the burden on the HREC, the sponsor and the participating centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-Time IGRT | Experimental | Device: Real-Time Image Guided Radio Therapy (IGRT)Real-Time IGRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older to be treated with curative radiation therapy
- Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer
- ECOG performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (3 listed)
- Pregnancy,
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation
- Additional inclusion and exclusion criteria may apply to a specific sub-study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time Image Guided Radio Therapy (IGRT)Real-time image guided radiation therapy (IGRT) methods image the cancerous tumour in real-time, enabling the treatment beam to focus its destructive energy on the patient's cancer, not their healthy tissue. | Device | Real-Time IGRT |
Primary outcome
Successful application of Real-Time IGRT
Time frame: From the date of enrolment until 90 days after the completion of radiotherapy treatment
Each real-time IGRT method under study is deemed feasible if successfully applied in 18 out of 20 consecutive patients (success rate of 90%), with a maximum of 40 patients to be included per cohort. If the real-time IGRT method is unsuccessfully applied in three consecutive patients or the real-time IGRT method is not successfully applied in 18 out of 20 consecutive patients after the inclusion of 40 patients, it is considered unfeasible. For each real-time IGRT method, success is defined by three general criteria (each of the three criteria should be met to reach feasibility): 1. All fractions per patient which are intended to be delivered with the real-time IGRT method are completed as planned 2. Absence of geographical miss in ≥85% of fractions or, in case of stereotactic treatments, in all minus one fraction. Geographical miss is defined as the clinical treatment volume outside the treated volume as measured on post-treatment image analysis 3. No unexpected grade >3 acute toxicities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. Aligned with the NHMRC's Open Access Policy and the Health Studies Australian National Data Asset (HeSANDA) program, the Real-Time IGRT trial will aim to make the de-identified trial data publicly available for other scientific research via an external research data repository, archive or register. E.g. The Cancer Imaging Archives (TCIA, https://www.cancerimagingarchive.net/). Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Keall principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Image Guided Radio Therapy (IGRT) in people with Cancer, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shona Silvester (+61 2 86271185, shona.silvester@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful application of Real-Time IGRT (time frame: From the date of enrolment until 90 days after the completion of radiotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.