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| Name | Class |
|---|---|
| University of Sydney | OTHER |
| Varian Medical Systems | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard SABR | No Intervention | Patients receive standard treatment | |
| MLC Tracking SABR | Experimental | Patients are treated with MLC tracking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLC Tracking | Device | Treat patient with Non FDA approved MLC Tracking |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate feasibility of MLC tracking for lung cancer | Percentage of fractions delivered without software or mechanical failure | Assessed at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Audio Visual (AV) Biofeedback | Fraction of patients for whom AV biofeedback improves breathing regularity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Eade, MD | RNSH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2112 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33263318 | Derived | Caillet V, Zwan B, Briggs A, Hardcastle N, Szymura K, Prodreka A, O'Brien R, Harris BE, Greer P, Haddad C, Jayamanne D, Eade T, Booth J, Keall P. Geometric uncertainty analysis of MLC tracking for lung SABR. Phys Med Biol. 2020 Dec 2;65(23):235040. doi: 10.1088/1361-6560/abb0c6. | |
| 33152399 | Derived | Booth J, Caillet V, Briggs A, Hardcastle N, Angelis G, Jayamanne D, Shepherd M, Podreka A, Szymura K, Nguyen DT, Poulsen P, O'Brien R, Harris B, Haddad C, Eade T, Keall P. MLC tracking for lung SABR is feasible, efficient and delivers high-precision target dose and lower normal tissue dose. Radiother Oncol. 2021 Feb;155:131-137. doi: 10.1016/j.radonc.2020.10.036. Epub 2020 Nov 3. |
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Data is to be shared with USyd to fulfil the secondary endpoints of the trial
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| Assessed at 2 years |
| Target volumes | Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning | Assessed at 2 years |
| Lung dose | Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning | Assessed at 2 years |
| Treated dose - MLC tracking | Difference between the treated dose and planned dose for MLC tracking | Assessed at 2 years |
| Treated dose - standard | Difference between the estimated treated dose and planned dose for ITV treatments | 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. | 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) | At time of treatment |
| D012140 |
| Respiratory Tract Diseases |