Characteristics of breathing-adapted gating using surface guidance for use in particle therapy: A phantom-based end-to-end test from CT simulation to dose delivery.

To account for intra-fractional tumor motion during dose delivery in radiotherapy, various treatment strategies are clinically implemented such as breathing-adapted gating and irradiating the tumor during specific breathing phases. In this work, we present a comprehensive phantom-based end-to-end test of breathing-adapted gating utilizing surface guidance for use in particle therapy. A commercial dynamic thorax phantom was used to reproduce regular and irregular breathing patterns recorded by the GateRT respiratory monitoring system. The amplitudes and periods of recorded breathing patterns were analysed and compared to planned patterns (ground-truth). In addition, the mean absolute deviations (MAD) and Pearson correlation coefficients (PCC) between the measurements and ground-truth were assessed. Measurements of gated and non-gated irradiations were also analysed with respect to dosimetry and geometry, and compared to treatment planning system (TPS). Further, the latency time of beam on/off was evaluated. Compared to the ground-truth, measurements performed with GateRT showed amplitude differences between 0.03 ± 0.02 mm and 0.26 ± 0.03 mm for regular and irregular breathing patterns, whilst periods of both breathing patterns ranged with a standard deviation between 10 and 190 ms. Furthermore, the GateRT software precisely acquired breathing patterns with a maximum MAD of 0.30 ± 0.23 mm. The PCC constantly ranged between 0.998 and 1.000. Comparisons between TPS and measured dose profiles indicated absolute mean dose deviations within institutional tolerances of ±5%. Geometrical beam characteristics also varied within our institutional tolerances of 1.5 mm. The overall time delays were <60 ms and thus within both recommended tolerances published by ESTRO and AAPM of 200 and 100 ms, respectively. In this study, a non-invasive optical surface-guided workflow including image acquisition, treatment planning, patient positioning and gated irradiation at an ion-beam gantry was investigated, and shown to be clinically viable. Based on phantom measurements, our results show a clinically-appropriate spatial, temporal, and dosimetric accuracy when using surface guidance in the clinical setting, and the results comply with international and institutional guidelines and tolerances.

Commissioning of Helium Ion Therapy and the First Patient Treatment With Active Beam Delivery.

PURPOSE: Helium ions offer intermediate physical and biological properties to the clinically used protons and carbon ions. This work presents the commissioning of the first clinical treatment planning system (TPS) for helium ion therapy with active beam delivery to prepare the first patients' treatment at the Heidelberg Ion-Beam Therapy Center (HIT). METHODS AND MATERIALS: Through collaboration between RaySearch Laboratories and HIT, absorbed and relative biological effectiveness (RBE)-weighted calculation methods were integrated for helium ion beam therapy with raster-scanned delivery in the TPS RayStation. At HIT, a modified microdosimetric kinetic biological model was chosen as reference biological model. TPS absorbed dose predictions were compared against measurements with several devices, using phantoms of different complexities, from homogeneous to heterogeneous anthropomorphic phantoms. RBE and RBE-weighted dose predictions of the TPS were verified against calculations with an independent RBE-weighted dose engine. The patient-specific quality assurance of the first treatment at HIT using helium ion beam with raster-scanned delivery is presented considering standard patient-specific measurements in a water phantom and 2 independent dose calculations with a Monte Carlo or an analytical-based engine. RESULTS: TPS predictions were consistent with dosimetric measurements and independent dose engines computations for absorbed and RBE-weighted doses. The mean difference between dose measurements to the TPS calculation was 0.2% for spread-out Bragg peaks in water. Verification of the first patient treatment TPS predictions against independent engines for both absorbed and RBE-weighted doses presents differences within 2% in the target and with a maximum deviation of 3.5% in the investigated critical regions of interest. CONCLUSIONS: Helium ion beam therapy has been successfully commissioned and introduced into clinical use. Through comprehensive validation of the absorbed and RBE-weighted dose predictions of the RayStation TPS, the first clinical TPS for helium ion therapy using raster-scanned delivery was employed to plan the first helium patient treatment at HIT.

Fluence inhomogeneities due to a ripple filter induced Moiré effect.

At particle therapy facilities with pencil beam scanning, the implementation of a ripple filter (RiFi) broadens the Bragg peak, so fewer energy steps from the accelerator are required for a homogeneous dose coverage of the planning target volume (PTV). However, sharply focusing the scanned pencil beams at the RiFi plane by ion optical settings can lead to a Moiré effect, causing fluence inhomogeneities at the isocenter. This has been experimentally proven at the Heidelberg Ionenstrahl-Therapiezentrum (HIT), Universitätsklinikum Heidelberg, Germany. 150 MeV u(-1) carbon-12 ions are used for irradiation with a 3 mm thick RiFi. The beam is focused in front of and as close to the RiFi plane as possible. The pencil beam width is estimated to be 0.78 mm at a 93 mm distance from the RiFi. Radiographic films are used to obtain the fluence profile 30 mm in front of the isocenter, 930 mm from the RiFi. The Monte Carlo (MC) code SHIELD-HIT12A is used to determine the RiFi-induced inhomogeneities in the fluence distribution at the isocenter for a similar setup, pencil beam widths at the RiFi plane ranging from σχ(RiFi to 1.2 mm and for scanning step sizes ranging from 1.5 to 3.7 mm. The beam application and monitoring system (BAMS) used at HIT is modelled and simulated. When the width of the pencil beams at the RiFi plane is much smaller than the scanning step size, the resulting inhomogeneous fluence distribution at the RiFi plane interfers with the inhomogeneous RiFi mass distribution and fluence inhomogeneity can be observed at the isocenter as large as an 8% deviation from the mean fluence. The inverse of the fluence ripple period at the isocenter is found to be the difference between the inverse of the RiFi period and the inverse of the scanning step size. We have been able to use MC simulations to reproduce the spacing of the ripple stripes seen in films irradiated at HIT. Our findings clearly indicate that pencil beams sharply focused near the RiFi plane result in fluence inhomogeneity at the isocenter. In the normal clinical application, such a setting should generally be avoided.

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit.

BACKGROUND: According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). METHODS: The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. RESULTS: The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. CONCLUSIONS: The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.

Heidelberg Ion Therapy Center (HIT): Initial clinical experience in the first 80 patients.

UNLABELLED: The Heidelberg Ion Therapy Center (HIT) started clinical operation in November 2009. In this report we present the first 80 patients treated with proton and carbon ion radiotherapy and describe patient selection, treatment planning and daily treatment for different indications. PATIENTS AND METHODS: Between November 15, 2009 and April 15, 2010, 80 patients were treated at the Heidelberg Ion Therapy Center (HIT) with carbon ion and proton radiotherapy. Main treated indications consisted of skull base chordoma (n = 9) and chondrosarcoma (n = 18), malignant salivary gland tumors (n=29), chordomas of the sacrum (n = 5), low grade glioma (n=3), primary and recurrent malignant astrocytoma and glioblastoma (n=7) and well as osteosarcoma (n = 3). Of these patients, four pediatric patients aged under 18 years were treated. RESULTS: All patients were treated using the intensity-modulated rasterscanning technique. Seventy six patients were treated with carbon ions (95%), and four patients were treated with protons. In all patients x-ray imaging was performed prior to each fraction. Treatment concepts were based on the initial experiences with carbon ion therapy at the Gesellschaft für Schwerionenforschung (GSI) including carbon-only treatments and carbon-boost treatments with photon-IMRT. The average time per fraction in the treatment room per patient was 29 minutes; for irradiation only, the mean time including all patients was 16 minutes. Position verification was performed prior to every treatment fraction with orthogonal x-ray imaging. CONCLUSION: Particle therapy could be included successfully into the clinical routine at the Department of Radiation Oncology in Heidelberg. Numerous clinical trials will subsequently be initiated to precisely define the role of proton and carbon ion radiotherapy in radiation oncology.