Status:
NOT_YET_RECRUITING
Nano-X Image Guidance: CBCT With Gravity-induced Motion
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
South Eastern Sydney Local Health District
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
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 al...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04488224
Start Date
September 1 2025
End Date
December 1 2026
Last Update
August 13 2025
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