Magnetic Resonance Imaging (MRI) guided audiovisual biofeedback for precise lung cancer radiotherapy

Phase 2

Completed

• Conditions: ung Cancer; Lung tumour motion consistency throughout medical imaging and radiotherapy procedures; Lung Cancer; Cancer - Lung - Non small cell; Cancer - Lung - Small cell

• Registration Number: ACTRN12615000163505
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Stage I-III lung cancer of any histology to be treated with radical radiotherapy with or without chemotherapy
Ability to have radiological scans, no contraindications to having an MRI scan
Ability to lie flat for about 1 hour 10 minutes

Exclusion Criteria

Metastatic disease
Pregnant women or those mentally impaired
People highly dependent on medical care
People unable to undergo MRI exam

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumour motion reproducibility with and without MRI guided audiovisual biofeedback. Results will be evaluated using the root mean square error (RMSE) method and compared using statistical analysis methods such as the students t-test.[After a minimum of 15 participants have been recruited. The primary outcome will be assessed following the second MRI session (mid treatment) for each participant.]

Secondary Outcome Measures

Name	Time	Method
Clinical benefit assessed as change in dose delivered to healthy tissues as a result of changes in tumour margins due to more consistant tumor motion achieved with four-dimensional MRI. MRI scans obtained before the start of radiotherapy and during radiotherapy treatment will be used. The treatment planning will be evaluated qualitatively by visual inspection of dose distribution and quantatively by analysing dose-volume metrics derived from dose-volume histograms (DVHs) and functional DVHs.[End of recruitment. This outcome will also be assessed following the second MRI session (mid treatment) for each participant.]