None listed
Conditions
Brief summary
The main aim of this study is to investigate liver tumour motion management using audiovisual (AV) biofeedback, and test the hypothesis that the more regular respiration as produced by AV biofeedback will result in more reproducible liver tumour motion which will have numerous clinical advantages. We will conduct a 30 liver cancer patient clinical CBCT imaging and correlative outcomes study. Who is it for? This study is open to liver cancer patients aged 18 and over with either primary hepatocellular carcinoma or liver metastases who are eligible for stereotactic radiotherapy. Patients will also need to have radio-opaque markers (fiducials and/or surgical clips) previously implanted in the liver. Trial Details In this study, participants will receive two additional cone-beam CT (CBCT) scans to investigate the impact of audiovisual (AV) biofeedback on liver tumour motion. AV biofeedback is a non-invasive, interactive respiratory guide designed to significantly reduce respiratory irregularities in order to maximise the accuracy of treatment planning as well as the efficiency of treatment delivery. The AV biofeedback system consists of a pair of audio-visual goggles that provide the participant with the audio and visual guidance-prompts. Each study session will take 1 hour to set up and pack up the equipment in addition to the two CBCT scans. There will be one study session for each of the 30 patients, the frequency of the study sessions will be dependent on the recruitment rate of liver cancer patients at RPA hospital. Hypothesis We hypothesize that the more regular respiration as produced by AV biofeedback will result in more reproducible liver tumour motion which will have numerous clinical advantages such as improved image quality, dose distributions and treatment margins.
Interventions
Audiovisual biofeedback is a non-invasive, interactive respiratory guide designed to significantly reduce respiratory irregularities in order to maximize the accuracy of treatment planning as well as the efficiency of treatment delivery.
The AV biofeedback system is comprised of audio-visual goggles that the patient wears to receive their audio and visual guiding prompts. The real-time respiratory input is provided by an infra-red camera tracking the motion of a marker positioned on the patient
Audiovisual biofeedback is a non-invasive, interactive respiratory guide designed to significantly reduce respiratory irregularities in order to maximize the accuracy of treatment planning as well as the efficiency of treatment delivery. The AV biofeedback system is comprised of audio-visual goggles that the patient wears to receive their audio and visual guiding prompts. The real-time respiratory input is provided by an infra-red camera tracking the motion of a marker positioned on the patient's abdomen. The AV biofeedback system will be implemented during two CBCT scans. By breathing with the guidance of AV biofeedback participants will wear the goggles and follow the audio and visual prompts as best they can. By breathing without the guidance of AV biofeedback, the participant does not wear the goggles, but their respiration motion is still monitored. As a part of their clinical treatment plan, the patients will already be having 18 CBCT scans; by participating in this study, they will have only two additional CBCT scans. The patients specifically undergoing SBRT are chosen because they will already have fiducial markers implanted about their liver tumours. SBRT does not form a part of this study. This AV biofeedback study will be conducted during their treatment planning phase when they are receiving numerous CBCT scans. Each study session will take a total of 1 hour inclusive of setting and packing up the AV biofeedback system in addition to the CBCT scans, but it may be completed in less time than this. After each session the patient will be asked to complete a questionnaire regarding the AV biofeedback system; each questionnaire is designed to only take 2 minutes to complete. The additional 2 CBCT scans for this study will be performed one after the other within the one hour study session. There is one study session for each patient, the frequency of study sessions will be dependent on the recruitment rate of liver cancer patients at RPA Hospital. The study session will be booked during the patient's treatment planning phase based on the availability of the patient's physician, radiation oncologist and medical physics staff.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Liver cancer patients, either primary hepatocellular carcinoma or liver metastases, eligible for stereotactic radiotherapy 2) > 18 years old 3) No gender or ethnic restrictions 4) Radio-opaque markers implanted (fiducials and/or surgical clips previously implanted in the liver) 5) Ability to give written informed consent and willingness to participate and comply with the study
Exclusion criteria
1) Pregnant/ lactating women 2) <18 years old. 3) Prior radiotherapy treatment to the liver 4) Life expectancy less than 6 months 5) Non-liver cancer patients
Outcome results
None listed