Lung CancerLAVANCT04323618
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback
A study testing Breathe Well in people with Lung Cancer, run by University of Sydney.
Trial summary
Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Breathe Well
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant / lactating women
About this study
Official title: Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing Stereotactic Body Radiotherapy Treatment (SBRT) Using Audiovisual (AV) Biofeedback
Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.
- Conditions
- Lung Cancer
- Being tested
- Breathe Well
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe WellDevice
| Study group | Role | What they receive |
|---|---|---|
| Free breathing or Breathe Well | Other | Free breathing or Breathe Well Receives: Device: Breathe Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in reproducibility of respiratory-related tumour motion (via fiducial maker surrogacy) for liver cancer patients treated with the AV biofeedback respiratory guidance system.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study startApr 2014
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323618
- Sponsor's protocol ID
- LAVA V4
- Acronym
- LAVA
- Status last verified
- Apr 2025
- First submitted
- 3 May 2018
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing Stereotactic Body Radiotherapy Treatment (SBRT) Using Audiovisual (AV) Biofeedback
- ClinicalTrials.gov ID
- NCT04323618
- Acronym / sponsor ID
- LAVA / LAVA V4
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Free breathing or Breathe Well | Other | Device: Breathe WellFree breathing or Breathe Well |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant / lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathe Well | Device | Free breathing or Breathe Well |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Breathe Well in people with Lung Cancer, run by University of Sydney.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.