Back to resultsInvestigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback (LAVA)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breathe Well
Sponsored by
About this trial
This is an interventional device feasibility trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Liver cancer patients, either primary hepatocellular carcinoma or liver metastases, eligible for stereotactic radiotherapy.
- >18 years old
- Radio-opaque markers implanted (fiducials and/or surgical clips previously implanted in the liver)
- Able to give written informed consent and willingness to participate and comply with the study
Exclusion Criteria:
- Pregnant / lactating women
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Free breathing or Breathe Well
Arm Description
Free breathing or Breathe Well
Outcomes
Primary Outcome Measures
Improvement in reproducibility of respiratory-related tumour motion (via fiducial maker surrogacy) for liver cancer patients treated with the AV biofeedback respiratory guidance system.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04323618
Brief Title
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback
Acronym
LAVA
Official Title
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing Stereotactic Body Radiotherapy Treatment (SBRT) Using Audiovisual (AV) Biofeedback
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sydney
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Free breathing or Breathe Well
Arm Type
Other
Arm Description
Free breathing or Breathe Well
Intervention Type
Device
Intervention Name(s)
Breathe Well
Primary Outcome Measure Information:
Title
Improvement in reproducibility of respiratory-related tumour motion (via fiducial maker surrogacy) for liver cancer patients treated with the AV biofeedback respiratory guidance system.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver cancer patients, either primary hepatocellular carcinoma or liver metastases, eligible for stereotactic radiotherapy.
>18 years old
Radio-opaque markers implanted (fiducials and/or surgical clips previously implanted in the liver)
Able to give written informed consent and willingness to participate and comply with the study
Exclusion Criteria:
Pregnant / lactating women
12. IPD Sharing Statement
Learn more about this trial
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback
We'll reach out to this number within 24 hrs