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

NCT06708221 | Not Yet Recruiting DMC

• 1 other identifier: RealTimeIGRT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cancer

Keywords

cancer; IGRT; radiotherapy; radiation therapy; Image Guided Radiation Therapy; breast cancer; lung cancer; Australia

Outcome Measures

Primary Outcomes (1)

• 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): 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

Study Arms (1)

Real-Time IGRT

EXPERIMENTAL

Real-Time IGRT

Device: Real-Time Image Guided Radio Therapy (IGRT)

Interventions

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.

Real-Time IGRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead
• Medical Research Future Fund: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paul Keall

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shona Silvester

CONTACT

+61 2 86271185; shona.silvester@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 27, 2024
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available following publication of final analysis, for a minimum of 5 years
• Access Criteria: Researchers will be able to access de-identified trial information from an external research data repository, archive or register.

Locations

AU (1)