The eValuation of Image Guidance of Stereotactic Body Radiotherapy Using Ultrasound: Assessment in Liver
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 主要终点
- Difference in liver position after set-up
研究概览
简要总结
Worldwide, primary liver cancer is the 3rd most common cause of cancer-related death, accounting for 6% of cancer diagnoses. In the UK, the number of cases reported has more than trebled since the 1970's, with 5550 new cases in 2014 (CRUK statistics 2014). Liver transplant or surgery are the main forms of treatment offered but only less than 20% of patients can tolerate these treatments. There is a need for non-surgical therapies that would improve these patients' chances of survival. Radiotherapy has been shown to increase the likelihood of liver cancer cure. To deliver radiotherapy safely to the patient, the radiation must be delivered to the liver cancer only, avoiding normal liver tissues and other surrounding normal tissues. Because the liver moves during breathing, a liver cancer will also move during radiotherapy. To accurately target the cancer the patient can be asked to hold their breath during treatment to stop the motion. Or motion of the cancer can be monitored and the radiation beam can be moved to follow its motion. The investigators are investigating new methods to either: (a) ensure that when the patient repeats their breath hold the cancer is in the same position each time, or (b) measure the motion of the liver cancer whilst the patient breathes freely. It is not clear which is the best method and therefore are investigating both approaches. Ultrasound is a non-invasive and real-time imaging method that can easily be used to image the liver and may be able to perform both of these tasks. In this study the investigators will test ultrasound equipment, which has been specifically designed to guide radiotherapy. 26 healthy volunteers will be recruited to help evaluate the accuracy of ultrasound to measure the position of the liver in breath hold and in free breathing.
详细描述
PURPOSE: This observational study of healthy volunteers will test the use of a safe, non-ionising and non-invasive imaging system for the purpose of improving radiotherapy treatment of the liver. This study investigates an image guidance method which may be used to guide liver radiotherapy and enable more accurate treatment on a conventional radiotherapy machine.
RECRUITMENT: Volunteers will need to provide their National Health Service (UK) numbers and be registered on the hospital information system. Volunteers need to be aware that if they are patients at the Royal Marsden Hospital this may raise confidentiality issues. Volunteers will be made aware of this in the recruiting email and the Volunteer Information sheet.
USE OF HEALTHY VOLUNTEERS: This is an observational study, which tests the use of an ultrasound guidance system. The accuracy of the system will be evaluated by comparison of proprietary methods of liver position estimation against a manually derived ground truth derived from the images of the liver acquired in participants. It is not expected that there are any differences in the ultrasound guidance images of healthy volunteers and patients with liver cancer. Ultrasound is a non-invasive and non-ionizing imaging modality with no known side-effects or complications and therefore, safe to use in a volunteer study. Furthermore, this study requires that participants lie on a hard couch for up to 45 minutes and up to 4 times. This would be challenging for the vast majority of patients with liver cancer who are most likely to be frail due to their disease.
REVIEW OF HEALTHY VOLUNTEERS: The ultrasound guidance system provides 3D ultrasound images of the liver for providing positional information only. It is very unlikely that abnormalities will be detectable on 3D US guidance images. These images are not of diagnostic quality, being lower resolution than routine diagnostic 2D ultrasound images. Furthermore, diagnostic ultrasound of the liver often incorporates ultrasound contrast agent, which will not be used in this study. If a radiographer does observe any abnormality, this will be reported to a Consultant Radiologist and the images will be made available for review.
RISKS, BURDENS and BENEFITS: There is very little risk associated with ultrasound and the Automatic Breathing Control (ABC) device, both pieces of the equipment are CE-marked and we are not using outside of their respective intended purposes. The burden to the volunteer is (1) the time spent, (2) the uncomfortable nature of the couch (it has a hard flat surface) and (3) discomfort using the ABC device. The participant will made aware of (1), (2) and (3) by providing details in the volunteer information sheet. Participants who are uncomfortable using the ABC can opt out and still participate in the study. Participants will be able to get up from the couch and walk around to relive any discomfort at any point during the imaging sessions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers.
排除标准
- •Healthy volunteers who are unable to hold their breath for 30 seconds in exhalation.
- •Healthy volunteers who are unable to lie for extended period of time (up to 45 minutes including short breaks of a few minutes) on a hard surface (treatment couch).
结局指标
主要结局
Difference in liver position after set-up
时间窗: Within 2 months of image acquisition
The mean difference in liver position measured by US-guide and using the gold standard method, measured in millimetres in the superior-inferior (SI), anterior-posterior (AP) and left-right (LR) directions over 5 set-up sessions.
次要结局
- Difference in liver position during repeat breath hold(Within 2 months of image acquisition)
- Liver motion between fractions and repeat thresholds(Within 2 months of image acquisition)
- Difference in liver position after set-up using Doppler ultrasound and US-guide(Within 2 months of image acquisition)
- Liver position during free-breathing(Within 2 months of image acquisition)
- Number of available imaging positions(Within 2 months of image acquisition)