Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking

Conditions
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Neoplasms, Lung Neoplasms

Intervention / Treatment
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* Device: MLC Tracking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or older Has provided written Informed Consent for participation in this trial and is willing to comply with the study Patients undergoing external beam radiotherapy at Northern Sydney Cancer Centre Histologically proven Stage I Non Small Cell Lung Cancer (NSCLC) oligometastatic lung metastases (3 or less). Histological diagnosis will be obtained if clinically indicated. MRI/4D-CT prior to insertion of Calypso beacons Patient must be able to have Varian Calypso beacons placed in the lung (if on anticoagulants, must be cleared by Local Medical Officer (LMO) or cardiologist). Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Body habitus enabling Calypso tracking (as per Calypso Determining a Patient's Localisation Designation & Orientation before implantation) A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately. Tumour diameter ≤ = 5cm Exclusion Criteria: Previous high-dose thoracic radiotherapy. Less than two Calypso beacons implanted in the lung. Calypso beacons are spaced by greater than 9cm or less than 1cm. Calypso beacons are less than 19cm from outer chest wall Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators) Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment Women who are pregnant or lactating. Unwilling or unable to give informed consent Unwilling or unable to complete quality of life questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard SABR<br>Patients receive standard treatment | |
| Experimental: MLC Tracking SABR<br>Patients are treated with MLC tracking | Device: MLC Tracking<br>* Treat patient with Non FDA approved MLC Tracking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Stereotactic Ablative Radiotherapy (SABR), MLC Tracking, Radiotherapy