Nano-X Image Guidance: CBCT With Gravity-induced Motion
NCT04488224 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2026-05-19
Summary
A pilot stage, device feasibility trial, to investigate the feasibility of acquiring cone beam computed tomography (CBCT) images for image guidance for radiation therapy by maintaining a fixed imaging system and rotating the participant about the horizontal axis using the Nano-X patient rotation system. It is a single-arm, controlled, single-blinded, non-treatment, non-invasive, single-institution trial.
Conditions
Interventions
- DEVICE
-
Nano-X Patient Rotation System
The Nano-X prototype is a horizontal patient rotation system that immobilises participants while being rotated on the horizontal axis. This device will be used to rotate patients horizontally while cone-beam Computed Tomography (CBCT) projections are acquired.
- RADIATION
-
Conventional CBCT scan
A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.
- OTHER
-
Psychometrically validated questionnaires
The Claustrophobia Questionnaire (CLQ), Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaires administered. CLQ only once before the first session, STAI and FMS both before and after each Nano-X CBCT session.
Sponsors & Collaborators
-
South Eastern Sydney Local Health District
collaborator OTHER_GOV -
University of Sydney
lead OTHER
Principal Investigators
-
Paul J Keall, PhD · ACRF Image X Institute, University of Sydney
-
Michael Jackson, MD · Prince of Wales Hospital
-
Simon Downes, MASc · Prince of Wales Hospital
-
Mark Gardner, PhD · ACRF Image X Institute, University of Sydney
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2025-12-11
- Completion
- 2025-12-11
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