Nano-X Image Guidance: CBCT With Gravity-induced Motion
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Nano-X Patient Rotation System (Device)
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.
干预措施: Psychometrically validated questionnaires (Other)
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.
干预措施: Nano-X Patient Rotation System (Device)
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.
干预措施: Conventional CBCT scan (Radiation)
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.
干预措施: Psychometrically validated questionnaires (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)