NCT04488224

Nano-X Image Guidance: CBCT With Gravity-induced Motion

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective: To investigate the feasibility of volumetric image guidance for the Nano-X patient rotation system (PRS). Secondary objectives: 1. To develop image reconstruction methods that allow target and normal tissue visualisation at all treatment angles to a clinical cone beam computed tomography (CBCT) standard. 2. To determine the reproducibility and variability in Nano-X CBCT compared to clinical CBCT. 3. To measure the magnitude of gravity-induced anatomical deformation and translation. 4. To develop treatment plan adaptation methods to compensate for gravity-induced target motion based on Nano-X CBCT image reconstruction at varying treatment angles. 5. To quantify the participant experience of horizontal rotation using the Nano-X PRS for volumetric image guidance CBCT acquisition. The investigators will perform a pilot stage, device feasibility trial, to investigate the feasibility of acquiring CBCT images for image guidance by maintaining a fixed imaging system and rotating the participant about the horizontal axis using the Nano-X PRS. It is a single-arm, controlled, single-blinded, non-treatment, non-invasive, single-institution trial. Eligible participants will be asked to attend the Nelune Comprehensive Cancer Centre (NCCC) at the Prince of Wales Hospital on two separate occasions to obtain Nano-X CBCT scans. For each scan the participant will be rotated 360° about the horizontal axis which will take approximately 72 seconds to complete. Participants will be asked to complete validated psychometric questionnaires before and after each Nano-X CBCT. The questionnaire responses will be used to quantify their experiences of anxiety and motion sickness, and report previous experiences of claustrophobia, in order to identify determinants of tolerance level. The projection data sets from the Nano-X CBCT scans, along with conventional CBCTs obtained for the participants' standard radiotherapy treatment, will be used to investigate the image-related objectives. The two Nano-X CBCT data sets from each participant will be used to compare Nano-X CBCT variability and reproducibility to clinical CBCT acquisition.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2020-07-27
• Last updated: 2025-08-13