A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods (Real-Time IGRT)

May 18, 2026 updated by: University of Sydney

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • Shankar Siva
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real-Time IGRT
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the date of enrolment until 90 days after the completion of radiotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

Medical Research Future Fund

Investigators

  • Principal Investigator: Paul Keall, University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RealTimeIGRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Available following publication of final analysis, for a minimum of 5 years

IPD Sharing Access Criteria

Researchers will be able to access de-identified trial information from an external research data repository, archive or register.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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