SBIR-STTR Award

The mission of TibaRay, Inc. is to develop and clinically translate next-generation radiation therapy technologies for the treatment of cancer, the single leading cause of death worldwide and increasing epidemically. A major advance in radiation therapy (RT) that has increased its curative potential and decreased side effects is the ability to sculpt radiation doses exquisitely in 3D to conform to tumors and spare surrounding normal organs. This dose sculpting is achieved by delivering radiation beams to the tumor from multiple directions, each of which has an optimized spatial intensity distribution. However, the fastest treatment times are still minutes long, limited by both beam intensities in electron linacs and the mechanical systems that are used to direct and shape the treatment beams. To address these major shortcomings of current state-of-the-art radiation delivery systems, TibaRay is proposing a radical new design for RT systems, Pluridirectional High-energy Agile Scanning Electronic Radiotherapy (PHASER), based on patented, novel technologies to produce intensity-modulated therapeutic energy x-ray beams from multiple directions using no mechanical systems to direct or shape the treatment beams. This is achieved by using an array of novel electron linacs each of which uses a magnetic electron beam scanning scheme paired with an extended bremsstrahlung target and multi-channel collimator array system referred to as Scanning Pencil-array-collimated High Speed Intensity-modulated X-ray source (SPHINX). The multiple linacs obviate the need to move a single linac on a gantry to achieve different beam directions and SPHINX eliminates the need for mechanical moving parts, e.g., multi-leaf collimators (MLCs), for therapy beam shaping. Each of the novel linacs used in PHASER are far more efficient and will generate more beam than conventional medical linacs. In the full PHASER design, it is estimated that the treatment time can be reduced to less than one second, effectively freezing physiological motion. The novel accelerator technology uses much simpler manufacturing techniques and production costs for PHASER are projected to be about the same as current state-of-the-art systems and maintenance/downtime costs should be lower. Initial proof of principle for the subsystems needed for PHASER have been demonstrated. TibaRay, in partnership with the Stanford University Department of Radiation Oncology and the SLAC National Acceleratory Laboratory, proposes to design (Phase I), build and test, and optimize a two-beam PHASER prototype (Phase II). In Phase III, TibaRay will develop the full PHASER prototype which will lead directly to commercialization and clinical translation. Our novel technology will help fill a tremendous worldwide need for high-quality, cost-effective radiation therapy for cancer.

Public Health Relevance Statement:
PROJECT NARRATIVE The goal of the proposal is to design a two-beam version of our Pluridirectional High-energy Agile Scanning Electronic Radiotherapy (PHASER) concept to improve the accuracy, precision, speed, and cost-effectiveness of radiation therapy for cancer. PHASER will enable the generation of high-resolution intensity-modulated radiation beams for rapid and exquisite 3-D radiation dose sculpting through all-electronic beam control, replacing the current state-of-the-art beam shaping through highly complex and failure-prone mechanical devices. PHASER enables treatment delivery fast enough to freeze the motion of moving tumors and will lead to more effective radiation treatments for cancer.

Project Terms:
3-Dimensional; Address; Adverse effects; Air; Anatomy; Animals; attenuation; base; beamline; cancer radiation therapy; cancer therapy; Cause of Death; Characteristics; Clinical; clinical translation; Collimator; commercialization; Complement; Complex; Conformal Radiotherapy; cost; cost effective; cost effectiveness; design; Development; Devices; Diagnostic; Dose; Electrical Engineering; Electron Beam; Electronics; Electrons; engineering design; External Beam Radiation Therapy; Extravasation; Failure; Feedback; Freezing; Frequencies; Funding; Generations; Geometry; Goals; Human; Image; imaging system; improved; innovation; Intensity-Modulated Radiotherapy; Killings; Laboratories; Lead; Legal patent; Linear Accelerator Radiotherapy Systems; Magnetism; Maintenance; Malignant Neoplasms; Marketing; Measures; Mechanics; Medical; Methodology; Minor; Mission; Motion; new technology; next generation; Normal tissue morphology; novel; operation; Organ; Output; Patients; Performance; Phase; Photons; Physics; Physiological; Plant Leaves; Positioning Attribute; Power Sources; Production; prototype; Radiation; Radiation Oncology; Radiation therapy; Resolution; Risk; Roentgen Rays; Scanning; Scheme; Shapes; Source; Speed; System; Techniques; Technology; Testing; Therapeutic; Time; Translating; treatment planning; tumor; Tumor Volume; Universities; Work; X-Ray Computed Tomography

The mission of TibaRay, Inc. is to develop and clinically translate next-generation radiation therapy technologies for the treatment of cancer, the single leading cause of death worldwide and increasing epidemically. A major advance in radiation therapy (RT) that has increased its curative potential and decreased side effects is the ability to sculpt radiation doses exquisitely in 3D to conform to tumors and spare surrounding healthy organs. This is achieved by delivering radiation beams to the tumor from multiple directions, each of which has an optimized spatial intensity distribution. However, the fastest treatment times are still minutes long, limited by both beam intensities in electron linacs and the mechanical systems that are used to direct and shape the beams. Recently, ultra-fast (<1s) high dose rate (300X) FLASH-RT has proven in pre-clinical studies to have high therapeutic index. But there is no existing technology to enable this therapy in the clinical, photon-based setting. To address these major shortcomings of current state-of-the-art radiation delivery systems, TibaRay has proposed a radical new design for RT systems, Pluridirectional High-energy Agile Scanning Electronic Radiotherapy (PHASER). It is based on patented, novel technologies to produce intensity-modulated therapeutic energy x-ray beams from multiple directions using no mechanical systems to direct (i.e. no rotating gantry) or shape the treatment beams (i.e. no mulit-leaf collimator). This is achieved by using an array of novel electron linacs each of which uses a magnetic electron beam scanning scheme paired with an extended bremsstrahlung target and multi-channel collimator array system referred to as Scanning Pencil-array-collimated High Speed Intensity-modulated X-ray source (SPHINX). Each of the novel linacs used in PHASER are far more efficient and will generate more beam than conventional medical linacs. In the full PHASER design, it is estimated that the treatment time can be reduced to <1s, effectively freezing physiological motion. The novel accelerator technology uses much simpler manufacturing techniques and production costs for PHASER are projected to be about the same as current state-of-the-art systems and maintenance/downtime costs should be lower. Initial proof of principle for the subsystems needed for PHASER have been demonstrated and design simulations have been performed in Phase 1. In Phase II, TibaRay, in partnership with the Stanford University Department of Radiation Oncology will optimize, build and test at first a single complete beam line with full maximum power. Then we will build and test a two-beam PHASER prototype to demonstrate the full rapid RF switching capability. These tests will be used to de-risk the primary working components of the system and will enable swift progress towards commercialization and clinical translation. Our novel technology will help fill a tremendous worldwide need for high-quality, cost-effective radiation therapy for cancer.

Public Health Relevance Statement:
PROJECT NARRATIVE The goal of the proposal is to design a two-beam version of our Pluridirectional High-energy Agile Scanning Electronic Radiotherapy (PHASER) concept to improve the accuracy, precision, speed, and cost-effectiveness of radiation therapy for cancer. PHASER will enable the generation of high-resolution intensity-modulated radiation beams for rapid and exquisite 3-D radiation dose sculpting through all-electronic beam control, replacing the current state-of-the-art beam shaping through highly complex and failure-prone mechanical devices. PHASER enables treatment delivery fast enough to freeze the motion of moving tumors and will lead to more effective radiation treatments for cancer using methods such as FLASH.

NIH Spending Category:
Bioengineering; Cancer; Radiation Oncology

Project Terms:
3-Dimensional; Abate; Address; base; beamline; Biology; cancer radiation therapy; cancer therapy; Cause of Death; Clinical; clinical translation; Collimator; commercialization; Complex; Contracts; cost; cost effective; cost effectiveness; design; Devices; Dose; Dose-Rate; Electron Beam; Electrons; Epidemic; Failure; Freezing; Funding; Generations; Goals; Guns; Hand; Image; improved; Infrastructure; innovation; Legal patent; Magnetism; Maintenance; Measures; Mechanics; Medical; Methods; Mission; Monitor; Motion; new technology; next generation; novel; off-patent; Organ; Output; Performance; Phase; phase 1 designs; Photons; Physiologic pulse; Physiological; Plant Leaves; preclinical study; Production; proton therapy; prototype; Radiation; radiation delivery; Radiation Dose Unit; Radiation Oncology; Radiation therapy; radio frequency; Resolution; Risk; Roentgen Rays; Scanning; Scheme; Science; Secure; Shapes; side effect; simulation; Small Business Innovation Research Grant; Source; Specific qualifier value; Speed; Study models; System; Techniques; Technology; Testing; Therapeutic; Therapeutic Index; Time; Tissues; Toxic effect; Translating; treatment planning; tumor; Universities; Work