Liver Neoplasms Clinical Trial
— VISUALOfficial title:
The eValuation of Image Guidance of Stereotactic Body Radiotherapy Using Ultrasound: Assessment in Liver
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.
Status | Not yet recruiting |
Enrollment | 26 |
Est. completion date | December 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy adult volunteers. Exclusion Criteria: - 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). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Institute of Cancer Research, United Kingdom |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Difference in liver position after set-up | 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. | Within 2 months of image acquisition | |
Secondary | Difference in liver position during repeat breath hold | 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 3 breath holds. | Within 2 months of image acquisition | |
Secondary | Difference in liver position after set-up using Doppler ultrasound and US-guide | The mean difference in liver position measured by B-mode US-guide and using the Doppler US-guide method, measured in millimetres in the superior-inferior (SI), anterior-posterior (AP) and left-right (LR) directions over 5 set-ups. | Within 2 months of image acquisition | |
Secondary | Liver position during free-breathing | The liver position measured in the SI, AP and LR directions, measured by 4D US-monitor during free breathing. | Within 2 months of image acquisition | |
Secondary | Liver motion between fractions and repeat thresholds | The mean motion of the liver during voluntary breath-hold and assisted breath-hold measured using the gold standard method. | Within 2 months of image acquisition | |
Secondary | Number of available imaging positions | The number of imaging positions (1 2 or 3), which may be used by 4D US-guide to accurately measure liver position during free-breathing. | Within 2 months of image acquisition |
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