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

NCT04488224 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: Nano-X IG
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Cancer

Keywords

Radiation Therapy; Image Guidance

Outcome Measures

Primary Outcomes (1)

• Number of Cone Beam Computed Tomography (CBCT) images acquired with horizontal patient rotation that are deemed to be of comparable image quality to clinical CBCT or deemed acceptable for radiotherapy image guidance as scored by a panel of experts.

  Observers will view the image sets in 3 orthogonal views and grade the image quality considering geometrical accuracy, anatomical visualisation, sharpness of the image, soft tissue contrast, image noise and uniformity and overall clinical usability. The imaging method will be deemed technically feasible if \>70% of CBCT images acquired with horizontal patient rotation are deemed of clinical quality.

  6 months

Secondary Outcomes (1)

• Change in Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaire scores before and after rotation as assessed by the Wilcoxon signed rank test.

  6 months

Study Arms (2)

Patients receiving CBCT Image Guidance during treatment

EXPERIMENTAL

On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session. Participants in this arm undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. These participants do not require an additional conventional CBCT as the SOC conventional CBCT images are used to benchmark the experimental Nano-X CBCT scans for evaluation of the primary outcome measure.

Device: Nano-X Patient Rotation System; Other: Psychometrically validated questionnaires

Patients not receiving CBCT Image Guidance during treatment

EXPERIMENTAL

On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session. Participants in this arm do not undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. As such these participants will receive an additional conventional CBCT scan on standard equipment which used to benchmark the experimental NAno-X CBCT scans for evaluation of the primary outcome measure.

Device: Nano-X Patient Rotation System; Radiation: Conventional CBCT scan; Other: Psychometrically validated questionnaires

Interventions

Nano-X Patient Rotation System DEVICE

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.

Patients not receiving CBCT Image Guidance during treatment; Patients receiving CBCT Image Guidance during treatment

Conventional CBCT scan RADIATION

A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.

Patients not receiving CBCT Image Guidance during treatment

Psychometrically validated questionnaires OTHER

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.

Patients not receiving CBCT Image Guidance during treatment; Patients receiving CBCT Image Guidance during treatment

Eligibility Criteria

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

You may qualify if:

• Cancer patients that are receiving radiation therapy that are able to be imaged with the Nano-X PRS with one of the following tumour sites:
• in the head/neck region
• in the chest/abdomen/pelvic region with fast CBCT used for standard of care image guidance and is aged 60 years or older
• in the chest/abdomen/pelvic region not receiving CBCT for standard of care image guidance and is aged 70 years or older
• diagnosis of lung cancer with stage II-IV
• ≥18 years of age
• ECOG Performance Status 0-2
• Must be able to communicate fluently in English to:
• i. Receive instructions from operators of the PRS for safety entering and leaving the Patient Rotation System and required conduct during the during the rotation session, and ii. Communicate their level of comfort or distress to operators of the equipment.
• Signed, written informed consent or approved alternative, non-contact method for informed consent.

You may not qualify if:

• Pregnant women
• Patients for whom attaining informed consent would not be possible, including mentally impairment
• Patients with severe vertigo or recent a diagnosis of Benign Paroxysmal Positioning Vertigo.

Sponsors & Collaborators

• University of Sydney: lead
• South Eastern Sydney Local Health District: collaborator

Related Publications (1)

• Debrot E, Liu P, Gardner M, Heng SM, Chan CH, Corde S, Downes S, Jackson M, Keall P. Nano X Image Guidance in radiation therapy: feasibility study protocol for cone beam computed tomography imaging with gravity-induced motion. Pilot Feasibility Stud. 2023 Jun 13;9(1):95. doi: 10.1186/s40814-023-01340-z.

  PMID: 37312127 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paul J Keall, PhD

  ACRF Image X Institute, University of Sydney

  PRINCIPAL INVESTIGATOR

• Michael Jackson, MD

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

• Simon Downes, MASc

  Prince of Wales Hospital

  STUDY CHAIR

• Mark Gardner, PhD

  ACRF Image X Institute, University of Sydney

  STUDY CHAIR

Central Study Contacts

Trial Coordinator

CONTACT

+61 2 8627 1185; shona.silvester@sydney.edu.au

Program Manager

CONTACT

+61 2 9114 0998; Hilary.Byrne@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Postdoctoral Research Associate will collect and de-identify CBCT images acquired during Nano-X rotation session and during participants' routine treatment. The software used to display the scans will incorporate a random number generator to determine the labeling of images as 'A' or 'B'. Observers assessing image quality for study outcomes will be masked to the source of either image.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo CBCT imaging during rotation on the Nano-X patient rotation system. For each participant, quality of CBCT images acquired during the rotation session will be compared with quality of CBCT images collected during their standard radiation therapy treatment.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 27, 2020
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: This data will become available upon completion of the study.