The eValuation of Image Guidance of Stereotactic Body Radiotherapy Using Ultrasound: Assessment in Liver

NCT03592550 | Unknown FDA Device

• 1 other identifier: CCR4821
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in liver position during repeat breath hold

  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

• Liver motion between fractions and repeat thresholds

  Within 2 months of image acquisition

• Number of available imaging positions

  Within 2 months of image acquisition

Study Arms (2)

Group A

Volunteers will be asked to receive ultrasound imaging in repeat voluntary breath hold and during free-breathing.

Device: Ultrasound imaging

Group B

Volunteers will be asked to receive ultrasound imaging in repeat voluntary breath hold and during free-breathing and in repeat spirometer assisted breath hold.

Device: Ultrasound imaging

Interventions

Ultrasound imaging DEVICE

Abdominal ultrasound imaging of the liver

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers drawn from staff at ICR and Royal Marsden Hospital

You may qualify if:

• Healthy adult volunteers.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emma J Harris, PhD

  Institute of Cancer Research, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma J Harris, PhD

CONTACT

+44 208 6613320; eharris@icr.ac.uk

Jeff C Bamber, PhD

CONTACT

+44 915 4562; jbamber@icr.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 19, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 24, 2018

Record last verified: 2018-07