The AVIATOR trial: A multicentre phase II randomised trial - netkey.at

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The AVIATOR trial: A multicentre phase II randomised trial of audio-visual investigation advancing thoracic radiotherapy Poster No.:

R-0282

Congress:

2014 CSM

Type:

Scientific Exhibit

Authors:

S. Pollock , K. Makhija , R. O'Brien , V. Gebski , F. Hegi-

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Johnson , J. Ludbrook , A. Rezo , R. Tse , T. Eade , R. 7

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Yeghiaian-Alvandi , S. Erin , K. Francis , P. Greer , S. Roderick , 1 1

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P. Keall ; SYDNEY/AU, GOSFORD/AU, WARATAH/AU, 4

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CANBERRA/AU, CAMPERDOWN/AU, ST LEONARDS/AU,

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WESTMEAD/AU

Keywords:

Thorax, Respiratory system, Lung, CT, Cone beam CT, Radiation therapy / Oncology, Radiotherapy techniques, Toxicity

DOI:

10.1594/ranzcr2014/R-0282

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Aim Irregular breathing can exacerbate errors in medical imaging and radiotherapy. The audiovisual (AV) biofeedback system is an advanced form of breathing training that has been proposed to facilitate regular patient respiration.

Fig. 1: AV Biofeedback: The patient, during either imaging (left) or treatment (right), matches their breathing to a personalised, computer-generated pattern of regular breathing (centre). References: University of Sydney - SYDNEY/AU The clinical benefits of AV biofeedback will be investigated in an upcoming multisite, randomised trial: Audio-Visual Investigation Advancing ThOracic Radiotherapy (AVIATOR)

Methods and materials There are seven oncology departments participating in the AVIATOR trial:

Fig. 2: AVIATOR study sites: Northern Sydney Cancer Centre, Westmead Hospital, Chris O'Brien Lifehouse, Canberra Hospital, Nepean Cancer Centre, Calvary Mater Hospital, Gosford Hospital References: University of Sydney, Northern Sydney Cancer Centre, Westmead Hospital, Chris O'Brien Lifehouse, Canberra Hospital, Nepean Cancer Centre, Calvary Mater Hospital, Gosford Hospital

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AVIATOR is a prospective, multi-institutional, randomised phase II clinical trial; the largest of its kind to date. A sample size of 50 lung cancer patients receiving the AV biofeedback system (intervention group) with 25 lung cancer patients receiving standard care (control group). The AVIATOR trial is also stratified by treatment intent (radical or palliateive) and oncology department.

Fig. 3: The AVIATOR trial design: a prospective multi-centre, phase 2, randomised clinical trial. References: University of Sydney - SYDNEY/AU

Results

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AVIATOR Checklist ACTION

STATUS

Open to Patient Recruitment

3 / 7 sites (July 18) Calvary Mater Newcastle, Hospital, Gosford Hospital

AV Biofeedback Tested in Department

Canberra

6 / 7 sites (July 18) Royal North Shore Hospital, Calvary Mater Newcastle, Canberra Hospital, Westmead Hospital, Gosford Hospital, Chris O'Brien Lifehouse.

AV Biofeedback Staff Training

2 / 7 sites (July 18) Calvary Mater Hospital

Newcastle,

Canberra

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Fig. 4: Lung tumour motion during Free Breathing (top) and AV Biofeedback (bottom). Data from an ongoing AV biofeedback study in Newcastle References: University of Sydney - SYDNEY/AU

Conclusion The AVIATOR trial is the culmination of ten years of research into respiratory guidance technology and will be the first & largest randomised multi-site breathing-guidance trial to date.

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Fig. 1: AV Biofeedback: The patient, during either imaging (left) or treatment (right), matches their breathing to a personalised, computer-generated pattern of regular breathing (centre). References: University of Sydney - SYDNEY/AU

Personal information Sean Pollock graduated with a B.Sc. majoring in physics and mathematics in 2010 before completing a Masters of Medical Physics in 2012 at the University of Sydney. Sean continues his studies at the University of Sydney with a PhD (Medicine) in the Radiation Physics Laboratory under the supervision of Paul Keall. The focus of Sean's PhD is spearheading the clinical investigation of the respiratory guidance system: audiovisual (AV) biofeedback.

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Fig. 5: The Radiation Physics Laboratory, University of Sydney. References: University of Sydney - SYDNEY/AU

References Irregular breathing leads to imaging errors and artefacts: (1) A.F. Abdelnour et al., "Phase and amplitude binning for 4D-CT imaging," Physics in medicine and biology 52, 3515-3529 (2007). (2) T. Yamamoto, U. Langner, B.W. Loo, Jr., J. Shen, P.J. Keall, "Retrospective Analysis of Artifacts in Four-Dimensional CT Images," Int J Radiat Oncol Biol Phys (2008). (3) W. Lu et al., "A comparison between amplitude sorting and phase-angle sorting using external respiratory measurement for 4D CT," Medical physics 33, 2964-2974 (2006). (4) Y.D. Mutaf, J.A. Antolak, D.H. Brinkmann, "The impact of temporal inaccuracies on 4DCT image quality," Medical physics 34, 1615-1622 (2007). (5) T. Pan, T.Y. Lee, E. Rietzel, G.T. Chen, "4D-CT imaging of a volume influenced by respiratory motion on multi-slice CT," Medical physics 31, 333-340 (2004). (6) E. Rietzel, G.T. Chen, K.P. Doppke, T. Pan, N.C. Choi, C.G. Willett, "4D computed tomography for treatment planning," Int J Radiat Oncol Biol Phys 57, S232-233 (2003). (7) G.F. Persson et al., "Deviations in delineated GTV caused by artefacts in 4DCT," Radiotherapy and Oncology 96, 61-66 (2010). (8) D.A. Low et al., "A novel CT acquisition and analysis technique for breathing motion modeling," Physics in Medicine and Biology 58, L31 (2013). (9) W. Sureshbabu, O. Mawlawi, "PET/CT imaging artifacts," Journal of nuclear medicine technology 33, 156-161 (2005). Irregular breathing leads to increased radiation toxicity: (10) Hope, A. J., P. E. Lindsay, et al. (2006). "Modeling radiation pneumonitis risk with clinical, dosimetric, and spatial parameters." International Journal of Radiation Oncology* Biology* Physics 65(1): 112-124. (11) Matsuo, Y., K. Shibuya, et al. (2012). "Dose-volume metrics associated with radiation pneumonitis after stereotactic body radiation therapy for lung cancer." International Journal of Radiation Oncology* Biology* Physics 83(4): e545-e549. (12) Wang, W., Y. Xu, et al. (2013). "Effect of Normal Lung Definition on Lung Dosimetry and Lung Toxicity Prediction in Radiation Therapy Treatment Planning." International Journal of Radiation Oncology* Biology* Physics 86(5): 956-963. (13) Scotti, V., L. Marrazzo, et al. (2014). "Impact of a breathing-control system on target margins and normal-tissue sparing in the treatment of lung cancer: experience at the radiotherapy unit of Florence University." La radiologia medica 119(1): 13-19.

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AV Biofeedback improves breathing regularity (improves image quality / treatment accuracy): (14) Kini, V. R. et al. Patient training in respiratory-gated radiotherapy. Medical Dosimetry 28, 7-11 (2003). (15) Vedam, S. S. et al. Quantifying the predictability of diaphragm motion during respiration with a noninvasive external marker. Med Phys 30, 505-513 (2003). (16) George, R., Ramakrishnan, V., Siebers, J. V., Chung, T. D. & Keall, P. J. Investigation of patient, tumour and treatment variables affecting residual motion for respiratory-gated radiotherapy, Phys Med Biol 51, 5305-5319, (2006). (17) George, R. et al. Audio-visual biofeedback for respiratory-gated radiotherapy : Impact of audio instruction and audio-visual biofeedback on respiratory-gated radiotherapy. Int J Radiat Oncol Biol Phys 65, 924-933 (2006). (18) Venkat, R. B., Sawant, A., Suh, Y., George, R. & Keall, P. J. Development and preliminary evaluation of a prototype audiovisual biofeedback device incorporating a patient-specific guiding waveform. Phys Med Biol 53, N197-208, (2008) (19) Yang, J., Yamamoto, T., Cho, B., Seo, Y. & Keall, P. J. The impact of audio-visual biofeedback on 4D PET images: results of a phantom study. Med Phys 39, 1046-1057, doi:10.1118/1.3679012 (2012). (20) Kim, T., Pollock, S., Lee, D., O'Brien, R. & Keall, P. Audiovisual biofeedback improves diaphragm motion reproducibility in MRI. Med Phys 39, 6921 (2012). (21) Pollock, S., Lee, D., Keall, P. & Kim, T. Audiovisual biofeedback improves motion prediction accuracy. Medical Physics 40, 041705 (2013). (22) Steel, H., Pollock, S., Lee, D., Keall, P. & Kim, T. The internal-external respiratory motion correlation is unaffected by audiovisual biofeedback. Australasian Physical & Engineering Sciences in Medicine, 1-6 (2014). (23) Lee, D., Greer, P., Arm, J., Keall, P. & Kim, T. in Journal of Physics: Conference Series. 012033 (IOP Publishing).

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The AVIATOR trial: A multicentre phase II randomised trial - netkey.at

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