Royal North Shore Hospital
St Leonards, New South Wales, 2112, Australia
NCT Number: NCT02514512
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
St Leonards, New South Wales, 2112, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treat patient with Non FDA approved MLC Tracking
Time frame: Assessed at 2 years
Percentage of fractions delivered without software or mechanical failure
Time frame: Assessed at 2 years
Fraction of patients for whom AV biofeedback improves breathing regularity
Time frame: Assessed at 2 years
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 between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning
Time frame: Assessed at 2 years
Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning
Time frame: Assessed at 2 years
Difference between the treated dose and planned dose for MLC tracking
Time frame: Assessed at 2 years
Difference between the estimated treated dose and planned dose for ITV treatments
Time frame: Assessed at 2 years
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: At time of treatment
To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)
Time frame: 5 years
Participants will be followed for 5 years to determine patient outcome3s, including radiation therapy toxicity, local control (whether the tumour has spread) and survival.
Royal North Shore Hospital
Other
Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking
Acronym: LIGHTSABR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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