CancerEarly Phase 1Nano-X IGNCT04488224
Nano-X Image Guidance: CBCT With Gravity-induced Motion
A Early Phase 1 study testing Nano-X Patient Rotation System, Conventional CBCT scan and Psychometrically validated questionnaires in people with Cancer, run by University of Sydney.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nano-X Patient Rotation System, Conventional CBCT scan and Psychometrically validated questionnaires
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 11 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- ECOG Performance Status 0-2
- Must be able to communicate fluently in English to:
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed description
Primary objective:
To investigate the feasibility of volumetric image guidance for the Nano-X patient rotation system (PRS).
Secondary objectives:
- 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.
- To determine the reproducibility and variability in Nano-X CBCT compared to clinical CBCT.
- To measure the magnitude of gravity-induced anatomical deformation and translation.
- To develop treatment plan adaptation methods to compensate for gravity-induced target motion based on Nano-X CBCT image reconstruction at varying treatment angles.
- 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
- Being tested
- Nano-X Patient Rotation System, Conventional CBCT scan, Psychometrically validated questionnaires
- Keywords
- Radiation Therapy, Image Guidance
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-X Patient Rotation SystemDevice
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 scanRadiation
A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.
Psychometrically validated questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nano-X Patient Rotation System; Radiation: Conventional CBCT scan; Other: Psychometrically validated questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Wilcoxon signed rank test used to determine statistically significant differences in anxiety and motion sickness assessed using psychometrically validated surveys completed prior to and post horizontal rotation CBCT scan.
The STAI questionnaire is used to assess anxiety and is comprised of 6 questions scored 1-4. These are combined for a final score between 6 and 24, where a higher number indicates a greater level of anxiety.
The FMS questionnaire is used to assess motion sickness. Participants rate their levels of motion sickness on a scale of 0-20 where 0 is no feeling of nausea and 20 is feeling terrible and very sick.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Sep 2025 (estimated)
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- South Eastern Sydney Local Health District
- Responsible party
- Sponsor
- Investigators
- Paul J Keall, PhD, Principal investigator, ACRF Image X Institute, University of SydneyMichael Jackson, MD, Principal investigator, Prince of Wales Hospital, Shatin, Hong KongSimon Downes, MASc, Study chair, Prince of Wales Hospital, Shatin, Hong KongMark Gardner, PhD, Study chair, ACRF Image X Institute, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488224
- Sponsor's protocol ID
- Nano-X IG
- Acronym
- Nano-X IG
- Status last verified
- May 2026
- First submitted
- 16 Jul 2020
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data may be provided to an external (non-university) research data repository, archive or register with the intention that it be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/board, under a materials transfer agreement with the university.
Publications
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.
PubMed 37312127
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-X Image Guidance: CBCT With Gravity-induced Motion
- ClinicalTrials.gov ID
- NCT04488224
- Acronym / sponsor ID
- Nano-X IG / Nano-X IG
- Conditions
- Cancer
- Keywords
- Radiation Therapy, Image Guidance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- South Eastern Sydney Local Health District
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To determine the reproducibility and variability in Nano-X CBCT compared to clinical CBCT.
- To measure the magnitude of gravity-induced anatomical deformation and translation.
- To develop treatment plan adaptation methods to compensate for gravity-induced target motion based on Nano-X CBCT image reconstruction at varying treatment angles.
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving CBCT Image Guidance during treatment | Experimental | Device: Nano-X Patient Rotation System, Other: Psychometrically validated questionnairesOn 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. |
| Patients not receiving CBCT Image Guidance during treatment | Experimental | Device: Nano-X Patient Rotation System, Radiation: Conventional CBCT scan, Other: Psychometrically validated questionnairesOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- ≥18 years of age
- ECOG Performance Status 0-2
- Must be able to communicate fluently in English to:
- Signed, written informed consent or approved alternative, non-contact method for informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-X Patient Rotation SystemThe 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. | Device | Patients not receiving CBCT Image Guidance during treatment, Patients receiving CBCT Image Guidance during treatment |
| Conventional CBCT scanA conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery. | Radiation | Patients not receiving CBCT Image Guidance during treatment |
| Psychometrically validated questionnairesThe 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. | Other | Patients not receiving CBCT Image Guidance during treatment, Patients receiving CBCT Image Guidance during treatment |
Primary outcome
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.
Time frame: 6 months
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.
1 secondary outcome
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.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 37312127Debrot 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.
- Individual participant dataSharing planned: Yes. De-identified study data may be provided to an external (non-university) research data repository, archive or register with the intention that it be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/board, under a materials transfer agreement with the university.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Keall, PhD principal investigator
ACRF Image X Institute, University of Sydney
Michael Jackson, MD principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
Simon Downes, MASc study chair
Prince of Wales Hospital, Shatin, Hong Kong
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nano-X Patient Rotation System, Conventional CBCT scan and Psychometrically validated questionnaires in people with Cancer, run by University of Sydney.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.