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

Sponsor
University of Sydney
Study ID
NCT06708221
Status
Not Yet Recruiting

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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Nov 27, 2024
Start date
Jun 30, 2027
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Real-Time IGRT
    Real-Time IGRT

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 ]

Central Contacts

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