NCT04323618

Brief Summary

Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable lung-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4.1 years

First QC Date

May 3, 2018

Last Update Submit

April 1, 2025

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Improvement in reproducibility of respiratory-related tumour motion (via fiducial maker surrogacy) for liver cancer patients treated with the AV biofeedback respiratory guidance system.

    2 years

Study Arms (1)

Free breathing or Breathe Well

OTHER

Free breathing or Breathe Well

Device: Breathe Well

Interventions

Breathe WellDEVICE
Free breathing or Breathe Well

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant / lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

March 26, 2020

Study Start

April 1, 2014

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 4, 2025

Record last verified: 2025-04