Publications

A selection of peer-reviewed papers as clinical presentations and posters to enhance understanding of the clinical benefit of the Raypilot system.

Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial

Alison C Tree, Peter Ostler, Hans van der Voet, William Chu, Andrew Loblaw, Daniel Ford, Shaun Tolan, Suneil Jain, Alexander Martin, John Staffurth, John Armstrong, Philip Camilleri, Kiran Kancherla, John Frew, Andrew Chan, Ian S Dayes, Aileen Duffton, Douglas H Brand, Daniel Henderson, Kirsty Morrison, Stephanie Brown, Julia Pugh, Stephanie Burnett, Muneeb Mahmud, Victoria Hinder, Olivia Naismith, Emma Hall*, Nicholas van As*, on behalf of the PACE Trial Investigators

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Background

Localised prostate cancer is commonly treated with external beam radiotherapy and moderate hypofractionation is non-inferior to longer schedules. Stereotactic body radiotherapy (SBRT) allows shorter treatment courses without impacting acute toxicity. We report 2-year toxicity findings from PACE-B, a randomised trial of conventionally fractionated or moderately hypofractionated radiotherapy versus SBRT.

Methods

PACE is an open-label, multicohort, randomised, controlled, phase 3 trial conducted at 35 hospitals in the UK, Ireland, and Canada. In PACE-B, men aged 18 years and older with a WHO performance status 0–2 and low-risk or intermediate-risk histologically-confirmed prostate adenocarcinoma (Gleason 4 + 3 excluded) were randomly allocated (1:1) by computerised central randomisation with permuted blocks (size four and six), stratified by centre and risk group to control radiotherapy (CRT; 78 Gy in 39 fractions over 7·8 weeks or, following protocol amendment on March 24, 2016, 62 Gy in 20 fractions over 4 weeks) or SBRT (36·25 Gy in five fractions over 1–2 weeks). Androgen deprivation was not permitted. Co-primary outcomes for this toxicity analysis were Radiation Therapy Oncology Group (RTOG) grade 2 or worse gastrointestinal and genitourinary toxicity at 24 months after radiotherapy. Analysis was by treatment received and included all patients with at least one fraction of study treatment assessed for late toxicity. Recruitment is complete. Follow-up for oncological outcomes continues. The trial is registered with ClinicalTrials.govNCT01584258.

Findings

We enrolled and randomly assigned 874 men between Aug 7, 2012, and Jan 4, 2018 (441 to CRT and 433 to SBRT). In this analysis, 430 patients were analysed in the CRT group and 414 in the SBRT group; a total of 844 (97%) of 874 randomly assigned patients. At 24 months, RTOG grade 2 or worse genitourinary toxicity was seen in eight (2%) of 381 participants assigned to CRT and 13 (3%) of 384 participants assigned to SBRT (absolute difference 1·3% [95% CI –1·3 to 4·0]; p=0·39); RTOG grade 2 or worse gastrointestinal toxicity was seen in 11 (3%) of 382 participants in the CRT group versus six (2%) of 384 participants in the SBRT group (absolute difference –1·3% [95% CI –3·9 to 1·1]; p=0·32). No serious adverse events (defined as RTOG grade 4 or worse) or treatment-related deaths were reported within the analysis timeframe.

Interpretation

In the PACE-B trial, 2-year RTOG toxicity rates were similar for five fraction SBRT and conventional schedules of radiotherapy. Prostate SBRT was found to be safe and associated with low rates of side-effects. Biochemical outcomes are awaited.

Funding

Accuray.

Intrafraction Prostate Motion Management During Dose-Escalated Linac-Based Stereotactic Body Radiation Therapy

Denis Panizza 1,2*, Valeria Faccenda 1,3, Raffaella Lucchini 2,4, Martina Camilla Daniotti 1,3, Sara Trivellato 1, Paolo Caricato 1,3, Valerio Pisoni 4, Elena De Ponti 1,2 and Stefano Arcangeli 2,4

1 Medical Physics Department, ASST Monza, Monza, Italy,

2 School of Medicine and Surgery, University of Milan Bicocca, Milan, Italy,

3 Department of Physics, University of Milan, Milan, Italy,

4 Radiation Oncology Department, ASST Monza, Monza, Italy

Conclusion: 
EM real-time tracking was successfully implemented for intrafraction motion management during dose-escalated prostate SBRT. Findings showed that most of the observed displacements were < 2 mm in any direction; however, there were a non-insignificant number of fractions with a motion exceeding the predefined threshold, which would have otherwise gone undetected without intrafraction motion management.

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ORIGINAL RESEARCH article

Front. Oncol., 07 April 2022 | https://doi.org/10.3389/fonc.2022.883725

[RSS 2022 Poster] Early Tolerance and Treatment Compliance to Linac-Based Prostate SBRT Using Real-Time Electromagnetic Tracking

Raffaella Lucchini, Denis Panizza, Valeria Faccenda, Veronica Vernier, Riccardo Ray Colciago, Stefano Arcangeli

School of Medicine and Surgery, University of Milan Bicocca, Milan, Italy
Radiation Oncology Departement, ASST Monza, Monza, Italy
Medical Physics Departement, ASST Monza, Monza, Italy
Departement of Physics, University of Milan, Milan, Italy

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Poster from The Radiosurgery Society® (RSS) Scientific Meeting 2022 in Carlsbad, CA

[RSS 2022 Poster] Electromagnetic Tracking of Intrafraction Prostate Motion During Dose-Escalated Linac-Based Stereotactic Body Radiation Therapy for Unfavorable Prostate Tumors

Denis Panizza, Raffaella Lucchini, Sara Trivellato, Valeria Faccenda, Paolo Caricato, Gianluca Montanari, Martina Camilla Daniotti, Valerio Pisoni, Elena De Ponti, Stefano Arcangeli

Medical Physics Departement, ASST Monza, Monza, Italy
School of Medicine and Surgery, University of Milan Bicocca, Milan, Italy
Radiation Oncology Departement, ASST Monza, Monza, Italy
Departement of Physics, University of Milan, Milan, Italy

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Poster from The Radiosurgery Society® (RSS) Scientific Meeting 2022 in Carlsbad, CA

Six degrees of freedom dynamic motion-including dose reconstruction in a commercial treatment planning system

Purpose:

Intrafractional motion during radiotherapy delivery can deteriorate the delivered dose. Dynamic rotational motion of up to 38 degrees has been reported during prostate cancer radiotherapy, but methods to determine the dosimetric consequences of such rotations are lacking. Here, we create and experimentally validate a dose reconstruction method that accounts for dynamic rotations and translations in a commercial treatment planning system (TPS). Interplay effects are quantified by comparing dose reconstructions with dynamic and constant rotations.

Simon Skouboe, Robin De Roover, Casper Gammelmark Muurholm, Thomas Ravkilde, Wouter Crijns, Rune Hansen, Tom Depuydt, Per Rugaard Poulsen.

Med Phys, 2021 Mar;48(3):1427-1435.

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Treatment outcome and compliance to dose-intensified linac-based SBRT for unfavorable prostate tumors using a novel real-time organ-motion tracking

Lucchini, R., Panizza, D., Colciago, R.R. et al.

Published in Radiation Oncology 16, 180 (2021).

Conclusions

Our preliminary findings show that dose intensified SBRT for unfavorable prostate tumors does not come at the cost of an increased toxicity, provided that a reliable technique for real time prostate monitoring is ensured. Fast FFF beams contributed to reduce intra-fractional motion. These observations need to be confirmed on a larger scale and a longer follow up.

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https://doi.org/10.1186/s13014-021-01908-0

 

[ESTRO 2021 Poster] - Real time intrafraction prostate motion during dose escalated linac based SBRT

Denis Panizza, Sara Trivellato, Gianluca Montanari, Valerio Pisoni, Valeria Faccenda, Paolo Caricato, Martina Camilla Daniotti, Raffaella Lucchini, Elena De Ponti, Stefano Arcangeli

Medical Physics Department and Radiation Oncology Department, ASST Monza, Monza, ItalySchool of Medicine and Surgery, University of Milan Bicocca, Milan, Italy

Poster from ESTRO 2021

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[ESTRO 2021 Poster] - Treatment compliance to linac-based prostate SBRT using real time electromagnetic tracking

Raffaella Lucchini, Denis Panizza, Veronica Vernier, Sara Trivellato, Stefano Arcangeli

Radiation Oncology Department, ASST Monza, Monza, Italy
School of Medicine and Surgery, University of Milan Bicocca, Milan, Italy

Poster from ESTRO 2021

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Modeling-Based Decision Support System for Radical Prostatectomy Versus External Beam Radiotherapy for Prostate Cancer Incorporating an In Silico Clinical Trial and a Cost–Utility Study

Simple Summary:

Low–intermediate prostate cancer has a number of viable treatment options, such as radical prostatectomy and radiotherapy, with similar survival outcomes but different treatmentrelated side effects. The aim of this study is to facilitate patient-specific treatment selection by developing a decision support system (DSS) that incorporates predictive models for cancer-free survival and treatment-related side effects. We challenged this DSS by validating it against randomized clinical trials and assessing the benefit through a cost–utility analysis. We aim to expand upon the applications of this DSS by using it as the basis for an in silico clinical trial for an underrepresented patient group. This modeling study shows that DSS-based treatment decisions will result in a clinically relevant increase in the patients’ quality of life and can be used for in silico trials.

Yvonka van Wijk et al. Cancers 2021, 13, 2687

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Quantitative investigation of dose accumulation errors from intrafraction motion in MRgRT for prostate cancer

Accurate spatial dose delivery in radiotherapy is frequently complicated due to changes in the patient’s internal anatomy during and in-between therapy segments. The recent introduction of hybrid MRI radiotherapy systems allows unequaled soft-tissue visualization during radiation delivery and can be used for dose reconstruction to quantify the impact of motion. To this end, knowledge of anatomical deformations obtained from continuous monitoring during treatment has to be combined with information on the spatio-temporal dose delivery to perform motion-compensated dose accumulation (MCDA).

L S Bosma et al 2021 Phys. Med. Biol. 66 065002

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Adapting to the motion of multiple independent targets using multileaf collimator tracking for locally advanced prostate cancer: Proof of principle simulation study

Purpose:

For patients with locally advanced cancer, multiple targets are treated simultaneously with radiotherapy. Differential motion between targets can compromise the treatment accuracy, yet there are currently no methods able to adapt to independent target motion. This study developed a multileaf collimator (MLC) tracking algorithm for differential motion adaptation and evaluated it in simulated treatments of locally advanced prostate cancer.

Emily A. Hewson et al.

Medical Physics, 48 (1), January 2021

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Delivered dose quantification in prostate radiotherapy using online 3D cine imaging and treatment log files on a combined 1.5T magnetic resonance imaging and linear accelerator system

The first MR-linac dose reconstruction results based on prostate tracking from intrafraction 3D cine-MR and treatment log files are presented. Such a pipeline is essential for online adaptation especially as we progress to MRI-guided extremely hypofractionated treatments.

Charis Kontaxis et al.

Physics and Imaging in Radiation Oncology 15 (2020) 23–29

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Dosimetric impact of intrafraction prostate rotation and accuracy of gating, multi-leaf collimator tracking and couch tracking to manage rotation: An end-to-end validation using volumetric film measurements

Conclusions:

Compensation of intrafraction prostate rotation with gating, MLC tracking and couch tracking was investigated experimentally for the first time. All three techniques improved the dosimetric accuracy, but residual motion-related dose errors remained due to the lack of rotation correction.

Robin De Roover et al.

Radiotherapy and Oncology 156 (2021) 10–18

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Dosimetric impact of soft-tissue based intrafraction motion from 3D cine-MR in prostate SBRT

To investigate the dosimetric impact of intrafraction translation and rotation motion of the prostate, as extracted from daily acquired post-treatment 3D cine-MR based on soft-tissue contrast, in extremely hypofractionated (SBRT) prostate patients.

D M de Muinck Keizer et. al.

Phys. Med. Biol. 65 (2020) 025012 (10pp)

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SBRT for localized prostate cancer: Biology meets Technology

White paper by Professor Stefano Arcangeli,

Ospedale San Gerardo, Monza, Italy

Università degli Studi di Milano Bicocca,

Facoltà di Medicina e Chirurgia, Milano, Italy

October 2020

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Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC):...

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial

Anders Widmark et al.

The Lancet Oncology: Volume 22, Issue 2, P235-245, February 01, 2021

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Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer

Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer

Charles N. Catton et al.

J Clin Oncol 2017; 35: 1884–90.

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Reconstruction of Intra-Fractional Prostate Movement and Its Effect on Dose Distribution

Lauri Järvinen1,2, Mikael Persson3, Oscar Sjöberg4, Per Ekström4, Erik Traneus3, Mikko Myllykangas1, Mikko Tenhunen1

1 Helsinki University Hospital, Cancer Center, Helsinki, Finland

2 Turku University Hospital, Department of Medical Physics & Department of Radiotherapy and Oncology, Turku, Finland

3 RaySearch Laboratories AB, Stockholm, Sweden

4 Micropos Medical AB, Gothenburg, Sweden

Poster with abstract, ESTRO 2020 Congress

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Analysis of the intra-fractional motion of the prostate during SBRT using an EM Transmitter

Michael Trainer1, Linda Carruthers1, Bill Nailon1, Susan Adamson1, Duncan McLaren1, Mike Kirby2

1Edinburgh Cancer Centre (ECC) UK

2Liverpool University Directorate of Radiotherapy UK

Poster with abstract, ASTRO 2020 Annual Meeting

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Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer

Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer

Himanshu R. Lukka et al.

Int J Radiat Oncol Biol Phys. 2018 Oct 1; 102(2): 287–295

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Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer

Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer

W. Robert Lee et al.

J Clin Oncol 2016; 34:2325–32.

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Hyprofractionated Versus Conventionally Fractionated Radiation Therapy: 7-Year Outcomes From the HYPRO Trial

Hyprofractionated Versus Conventionally Fractionated Radiation Therapy for Patients with Intermediate- or High-Risk, Localized, Prostate Cancer: 7-Year Outcomes From the Randomized, Multicenter, Open-Label, Phase 3 HYPRO Trial

Luca Incrocci et al.

Lancet Oncol 2016; 17: 1061–69

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Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes...CHHiP trial.

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

David Dearnaley et al.

Lancet Oncol 2016; 17: 1047–60.

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Real-Time Ultrasound and Electromagnetic Transmitter Based Tracking Systems for Adaptive Radiotherapy in Prostate Cancer Patients

M.C. Biston 1,2, L. Delcoudert1, C. Gorsse1, A. Munoz1, P. Pommier1
1Centre Leon Berard, Lyon, France
2Universite  de Lyon, CREATIS; CNRS UMR5220; Inserm U1044; INSA-Lyon Universite  1, Lyon Cedex 08, France

Oral presentation, Abstract, Electronic Poster, ASTRO 2017, San Diego, USA

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The effect of rectal retractor on intrafraction motion of the prostate (Publication)

A. Vanhanen1,2, M. Kapanen1,2
1Department of Oncology, Unit of Radiotherapy, Tampere University Hospital, PO Box 2000, FI-33521 Tampere, Finland
2Department of Medical Physics, Medical Imaging Center, Tampere University Hospital, PO Box 2000, FI-33521 Tampere, Finland

Publication in Biomed. Phys. Eng. Express 2 (2016) 035021

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The effect of rectal retractor on intrafraction motion of the prostate (Poster)

A. Vanhanen1,2, M. Kapanen1,2
1Department of Oncology, Unit of Radiotherapy, Tampere University Hospital, POB-2000, 33521 Tampere, Finland
2Department of Medical Physics, Medical Imaging Center, Tampere University Hospital, POB-2000, 33521 Tampere, Finland

Poster with abstract, ESTRO 35, 2016, Turin, Italy

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Intrafraction motion assessment in SBRT for prostate cancer: a prospective study

Alessandro Vai1, Alessio Pierelli1, Federica Locatelli1, Vittorio Vavassori2, Elisa Della Bosca2, Andrea Ravasio2, Micaela Motta2 , Viviana Manazzale2, Paolo Salmoiraghi1
1Medical Physics Department, Humanitas Gavazzeni, Bergamo, Italy
2Radiotherapy Department, Humanitas Gavazzeni, Bergamo, Italy

Poster with abstract, Italian SBRT kongress at University of Milan, October 2014

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Echtzeituntersuchung der intrafraktionellen Prostatamobilität bei der definitiven perkutanen Strahlentherapie mittels eines implantierbaren Radiotransmitters unter Verwendung eines endorektalen Ballons.

Lewitzki V. 1, Kühn A. 2, Gocke C. 1, Syren H. 3, Knauerhase H. 1, Hildebrandt G. 1
1Klinik und Poliklinik für Strahlentherapie, Universitätsmedizin Rostock
2Medizinische Fakultät, Universität Rostock
3Micropos Medical AB

Poster with abstract, DEGRO 2014, Düsseldorf

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Prostate intrafraction motion assessment using a temporary-implanted wired electromagnetic tracking system

Alessandro Vai1, Alessio Pierelli1, Federica Locatelli1, Vittorio Vavassori2, Elisa Della Bosca2, Andrea Ravasio2, Micaela Motta2, Viviana Manazzale2, Paolo Salmoiraghi1
1Medical Physics Department, Humanitas Gavazzeni, Bergamo, Italy
2Radiotherapy Department, Humanitas Gavazzeni, Bergamo, Italy

Poster with abstract, ESTRO 33, 2014, Vienna, Austria

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Real-time dose reconstruction during volumetric modulated arc therapy with dynamic MLC tracking

ESTRO-Jack Fowler University of Wisconsin Award
At ESTRO 33 (2014) in Vienna, Thomas Ravkilde was awarded for the work on MLC tracking that has been performed in cooperation with Ass. Prof. Per Rugaard Poulsen at the Aarhus University Hospital in Denmark and Prof. Paul Keall at the Radiation Physics Laboratory, Sydney, Australia.

Click here to watch MLC tracking performed at the Aarhus University hospital on the RayPIlot® system and a Varian RapidArc® Clinac

Real-time intrafraction target motion evaluation in prostate cancer radiotherapy using a temporary-implanted wired electromagnetic transmitter: influence on treatment margin

Alessandro Vai1, Alessio Pierelli1, Federica Locatelli1, Vittorio Vavassori2, Elisa Della Bosca2, Andrea Ravasio2, Micaela Motta2, Viviana Manazzale2, Paolo Salmoiraghi1
1Medical Physics Department, Humanitas Gavazzeni, Bergamo, Italy
2Radiotherapy Department, Humanitas Gavazzeni, Bergamo, Italy

Poster with abstract, The 8th National Congress, AIFM 2013, Torino, Italy

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Experimentally validated simulator of dynamic MLC tracking treatments: A tool for tracking QA.

Poulsen PR1, Ravkilde T1, O’Brien RT2, Keall PJ2
1Aarhus University Hospital, Aarhus, Denmark
2The University of Sydney, Sydney, Australia

Oral presentation with abstract, Int J Rad Onc Biol Phys 2013: 87, Suppl, S45. (ASTRO 55th Annual Meeting, Atlanta, Sept. 2013).
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Time-resolved measurements and reconstruction of delivered target dose in VMAT treatments with and without dynamic MLC tracking: predicting treatment delivery success.

Ravkilde T1,2, Keall PJ3, Grau C1,2, Høyer M1,2, Poulsen PR1,2
1Department of Oncology, Aarhus University Hospital, Aarhus, Denmark
2Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark
3Radiation Physics Laboratory, University of Sydney, Sydney, Australia

Oral presentation with abstract, BiGART2013

Time-resolved dose distributions to moving targets during volumetric modulated arc therapy with and without dynamic MLC tracking.

Ravkilde T1,2, Keall PJ3, Grau C1,2, Høyer M1,2, Poulsen PR1,2
1Department of Oncology, Aarhus University Hospital, Aarhus, Denmark
2Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark
3Radiation Physics Laboratory, University of Sydney, Sydney, Australia

Article, Medical Physics 2013: 40; 111723-1-6
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Time-resolved dose reconstruction by motion encoding of volumetric modulated arc therapy fields delivered with and without dynamic multi-leaf collimator tracking.

Ravkilde T1,2, Keall PJ3, Grau C1,2, Høyer M1,2, Poulsen PR1,2
1Department of Oncology, Aarhus University Hospital, Aarhus, Denmark
2Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark
3Radiation Physics Laboratory, University of Sydney, Sydney, Australia

Article, Acta Oncologica 2013: 52; 1497-1503
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Dosimetric verification of complex radiotherapy with a 3D optically based dosimetry system: Dose painting and target tracking.

Skyt PS, Petersen JBB, Yates ES, Poulsen PR, Ravkilde TL, Balling P, Muren LP.
Department of Medical Physics, Aarhus University/Aarhus University Hospital, Aarhus, Denmark

Article, Acta Oncologica 2013: 52; 1445-1450
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