An interventional study of MLC Tracking in Neoplasms and Lung Neoplasms, sponsored by Royal North Shore Hospital. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Royal North Shore Hospital · Not applicable, Interventional, and Treatment
A research study into a new technology for adjustment of the radiotherapy beam to account for movement of lung tumours as the patient breathes during radiotherapy.
Twenty patients 18 years of age or more and undergoing Stereotactic Body Radiotherapy (SBRT) at Northern Sydney Cancer Centre for lung cancer will receive the new treatment. Participants will be physically able to undergo all aspects of treatment and intellectually able to provide written informed consent and complete questionnaires. Beacons will be implanted in the patients' lung to allow the Multi Leaf Collimator (MLC) tracking equipment to follow precisely the movement of the lung. The difference in ability to track tumour movement between MLC and the current standard method will be compared to identify changes in study outcomes. Audiovisual (AV) Biofeedback will also be used to regulate patients' breathing during radiotherapy.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Royal North Shore Hospital is the lead sponsor of 29 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard treatment
Patients are treated with MLC tracking
Device: MLC Tracking
Treat patient with Non FDA approved MLC Tracking
To demonstrate feasibility of MLC tracking for lung cancer
Percentage of fractions delivered without software or mechanical failure
Time frame: Assessed at 2 years
Audio Visual (AV) Biofeedback
Fraction of patients for whom AV biofeedback improves breathing regularity
Time frame: Assessed at 2 years
Coefficient of variation in breathing patterns
Breathing variations over imaging and treatment sessions with and without AV biofeedback using a statistical process for coefficient of variation
Time frame: Assessed at 2 years
Target volumes
Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning
Time frame: Assessed at 2 years
Lung dose
Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning
Time frame: Assessed at 2 years
Treated dose - MLC tracking
Difference between the treated dose and planned dose for MLC tracking
Time frame: Assessed at 2 years
Treated dose - standard
Difference between the estimated treated dose and planned dose for ITV treatments
Time frame: Assessed at 2 years
4D Cone Beam CT (CBCT) image quality
Image quality and target position differences between the Calypso-based 4D CBCT image reconstruction and Revs Per Minute (RPM)-based 4D CBCT image reconstruction using Feldkamp filtered backprojection (FDK and iterative reconstruction algorithms.
Time frame: Assessed at 2 years
Breathing variations with and without continuous positive air pressure (CPAP)
To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)
Time frame: At time of treatment
Patient Outcomes - Composite
Participants will be followed for 5 years to determine patient outcome3s, including radiation therapy toxicity, local control (whether the tumour has spread) and survival.
Time frame: 5 years
Plan to share: Yes — Data is to be shared with USyd to fulfil the secondary endpoints of the trial
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Royal North Shore Hospital