Nano-X Image Guidance: CBCT With Gravity-induced Motion
NCT ID: NCT04488224
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-09-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Patients receiving CBCT Image Guidance during treatment
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.
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.
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.
Patients not receiving CBCT Image Guidance during treatment
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.
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.
Conventional CBCT scan
A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.
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.
Interventions
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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.
Conventional CBCT scan
A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.
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.
Eligibility Criteria
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Inclusion Criteria
1. in the head/neck region
2. in the chest/abdomen/pelvic region with fast CBCT used for standard of care image guidance and is aged 60 years or older
3. in the chest/abdomen/pelvic region not receiving CBCT for standard of care image guidance and is aged 70 years or older
4. diagnosis of lung cancer with stage II-IV
2. ≥18 years of age
3. ECOG Performance Status 0-2
4. 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.
5. Signed, written informed consent or approved alternative, non-contact method for informed consent.
Exclusion Criteria
2. Patients for whom attaining informed consent would not be possible, including mentally impairment
3. Patients with severe vertigo or recent a diagnosis of Benign Paroxysmal Positioning Vertigo.
18 Years
ALL
No
Sponsors
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South Eastern Sydney Local Health District
OTHER_GOV
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Paul J Keall, PhD
Role: PRINCIPAL_INVESTIGATOR
ACRF Image X Institute, University of Sydney
Michael Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Simon Downes, MASc
Role: STUDY_CHAIR
Prince of Wales Hospital
Mark Gardner, PhD
Role: STUDY_CHAIR
ACRF Image X Institute, University of Sydney
Central Contacts
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References
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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.
Other Identifiers
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Nano-X IG
Identifier Type: -
Identifier Source: org_study_id
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