FDA clears BrainLAB's Monte Carlo Dose Calculation Algorithm for therapeutic photon beams

July 31, 2008 -- BrainLAB (Munich, Germany) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Monte Carlo Dose Calculation Algorithm for therapeutic photon beams. The Monte Carlo algorithm is considered the gold standard for treatment planning of lung and head and neck tumors, but its clinical implementation has been limited because of numerous factors that BrainLAB has worked to overcome.

July 31, 2008 -- BrainLAB (Munich, Germany), developer of software-driven systems for targeted, less-invasive medical treatments, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Monte Carlo Dose Calculation Algorithm.

The Monte Carlo algorithm is widely accepted as the gold standard for calculation in treatment planning accuracy. But, its clinical implementation has been limited because of numerous factors including time requirements, and restriction of treatment-planning software to a single machine or treatment modality.

BrainLAB developed its new software to make high-precision treatment available in everyday clinical practice. In fact, the software is already being used at several clinical cooperation sites worldwide. The Monte Carlo algorithm for therapeutic photon beams supports nearly all linear accelerator and multi-leaf collimator (MLC) types. The dose calculation engine can be seamlessly integrated with Varian, Siemens, and Elekta MLCs and linear accelerators; it supports a wide range of treatment plans, including conformal beam, static and dynamic arc, and IMRT treatment modalities.

Monte Carlo is now available as an option on the iPlan RT Dose treatment planning software. Dose calculations can be completed within seconds for conformal beam and dynamic arc treatments and within a few minutes for complex IMRT cases.

"The new BrainLAB Monte Carlo algorithm integrates some of the most advanced image registration and segmentation tools available in the clinical environment, providing a powerful tool to tackle the most challenging radiosurgery cases in lung and head & neck sites. It is clearly a much needed advancement in the field of radiosurgery treatment planning," said Kamil Yenice, Ph.D., Chief of Clinical Physics, University of Chicago, Department of Radiation and Cellular Oncology.

"We believe that the release of the BrainLAB Monte Carlo Dose Calculation Algorithm will have a great impact on the field of radiosurgery. We continue to develop software solutions that extend clinicians' treatment precision to cover more extra-cranial cancers as well as advanced dose calculation possibilities for lung and head and neck tumors," said David J. Brett, Product Manager iPlan Oncology, BrainLAB.

The Monte Carlo Dose Algorithm was developed by physicist Matthias Fippel, Ph.D., Senior Software Engineer at BrainLAB, who has published numerous clinical papers on the subject over the past 10 years. Fippel is seen to be one of the foremost experts in the field and previously worked on Monte Carlo research projects at the University of Leipzig and the University of Tubingen in Germany. The Monte Carlo Dose Calculation Algorithm is based on the XVMC (X-Ray Voxel Monte Carlo) algorithm and has been verified using the EGSnrc and BEAMnrc software algorithms. The advanced dose calculation solution from BrainLAB is based on the Monte Carlo method of modeling the transport of radiation through a beam collimation system (MLC) and through human tissue. Monte Carlo requires a 3D CT-scan of the patient's tissue to create an internal model of the patient and to calculate the dose distribution of the radiation emitted by a linear accelerator. The present implementation is designed to model photon radiation.

Conventional dose calculation algorithms, such as Pencil Beam, were used for cranial as well as extra-cranial indications before the application of the Monte Carlo method in the field of radiation therapy. Pencil Beam has proven effective for tumors located in homogeneous regions with similar tissue consistency such as the brain. However, these algorithms tend to overestimate the dose distribution in extra-cranial tumors such as in the lung and head and neck regions where large inhomogenities exist because of the proximity of bone, soft tissue and air cavities. Due to the inconsistencies seen in current calculation methods for extra-cranial treatments and the need for more precise radiation delivery, research has led to the creation and integration of improved calculation methods into treatment planning.

Many clinicians see the Monte Carlo Dose Calculation Algorithm as a superior algorithm for lung and head & neck treatments as compared to other computing algorithms, such as the collapsed cone or convolution methods.

The BrainLAB Monte Carlo Dose Calculation Algorithm is an integral part of BrainLAB's iPlan RT Dose software version 4 and provides clinicians with additional dose planning options, offering more informed treatment planning and improved clinical outcomes.

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