SBIR-STTR Award

Development of a Versatile Robotic Radiation Therapy System
Award last edited on: 11/17/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$4,532,470
Award Phase
2
Solicitation Topic Code
393
Principal Investigator
Salime Max Boucher

Company Information

RadiaBeam Technologies LLC (AKA: Radia Technologies Corporation~RadiaBeam Systems LLC~RadiaBeam Systems, LLC)

1735 Stewart Street Suite A
Santa Monica, CA 90404
   (310) 822-5845
   info@radiabeam.com
   www.radiabeam.com
Location: Single
Congr. District: 36
County: Los Angeles

Phase I

Contract Number: 1R43CA183390-01A1
Start Date: 4/1/2015    Completed: 3/31/2016
Phase I year
2015
Phase I Amount
$224,741
Robotic radiotherapy using extensively non-coplanar beams has been shown effective to significantly improve radiation therapy dosimetry that leads to improved treatment outcome. However, current implementation of this technique by CyberKnife is inefficient and not optimal dosimetrically. This has severely limited both the number of patients eligible for robotic radiotherapy and the achievable clinical outcome for those who have been treated. In order to overcome these limitations, we propose to develop a novel robotic radiotherapy system that can efficiently utilize the full potential of the non-coplanar delivery space to treat the majority of radiotherapy patients. Innovation: The proposed system is highly innovative in the following aspect: 1) Integrated beam orientation and fluence optimization. 2) Significantly more compact linac to allow posterior beams. 3) Flexible field sizes and MLC resolution to efficiently treat most target sizes. 4) Integrated volumetric imaging system. This project is proposed to design a hardware platform materializing such robotic radiotherapy system. In order to reduce the gantry size, both the linac length and the distance between the source and the MLC need to be significantly reduced. We propose to design a new 2 MV source to reduce linac length and provide the required dose rate for treatment. The physical MLC leaf thickness cannot be substantially thinner than 1 mm. To achieve a high MLC resolution at the treatment distance, a spacer is used in CyberKnife between the primary collimator and the MLC, increasing the gantry dimension. We propose to eliminate the spacer but vary the focus-to-tumor distances (FTD) to achieve desired field size and MLC resolution. This requires optimization in an enormous solution space, a capacity uniquely demonstrated by the 4p algorithm. Volumetric imaging has been an indispensable component of modern radiotherapy but unfortunately missing from existing robotic systems. The proposed new linac will be able to deliver kV imaging beams from the same 2 MV linac, which in combination with gantry or couch mounted imagers will allow volumetric imaging for more precise tumor targeting. Aims: 1: Prototypical design of the accelerator to produce 2 MV X-rays 2: Design incorporated imaging system 3: Develop a conceptual design for the entire clinical system Impact: Success of the Phase I project would lead to the design of the first 2 MV linear accelerator capable of producing a competitively high dose rate of >800 cGy/min at 100 cm and kV imaging beams for image guided radiotherapy. This paves the technical path to a new robotic radiotherapy system delivering radiation plans with dose conformality surpassing existing X-ray platforms. More importantly, the significantly increased field size, throughput and the volumetric imaging capacity would allow the new robotic system to compete for a much larger market, including that for conventional linacs, than the niche market CyberKnife currently commands.

Public Health Relevance Statement:


Public Health Relevance:
Success of the proposed project would lead to the development of a novel radiation therapy device capable of significantly reducing the radiation dose deposited to healthy tissue during cancer treatment. The final clinical system to be developed in Phase II would revolutionize the field of radiation therapy by allowing this precise tumor targeting to be achieved with a quick, flexible robotic system enabling high patient throughput. This system is expected to manage a wide range of diseases and treatment fractions, thus having a broad clinical and commercial impact.

Project Terms:
Affect; Algorithms; arm; cancer therapy; Clinical; Collimator; cost; Data; Deposition; design; Development; Devices; Dimensions; Disease; Dose; Dose-Rate; dosimetry; Drops; Electrons; Eligibility Determination; Extravasation; Eye; falls; flexibility; Frequencies (time pattern); Head; Head and neck structure; Image; improved; innovation; Lead; Length; Linear Accelerator Radiotherapy Systems; Marketing; Methods; Monitor; Motion; Normal tissue morphology; novel; Outcome; Output; patient population; Patients; Phase; phase 1 study; Plant Leaves; Power Sources; Production; public health relevance; Radiation; Radiation therapy; Radiometry; Research; Resolution; Robot; Robotics; Roentgen Rays; simulation; Solid; Solutions; Source; Spottings; success; System; Techniques; Testing; Thick; Time; Tissues; Treatment outcome; tumor; Weight; Work

Phase II

Contract Number: 2R44CA183390-02A1
Start Date: 6/19/2016    Completed: 3/31/2020
Phase II year
2017
(last award dollars: 2023)
Phase II Amount
$4,307,729

Significance: Robotic radiotherapy using extensively non-coplanar beams has been shown effective to significantly improve radiation therapy dosimetry, leading to improved treatment outcomes. However, the current implementation of this technique by CyberKnife is inefficient and not dosimetrically optimal. This has severely limited both the number of patients eligible for robotic radiotherapy and the achievable clinical outcome for those who have been treated. In order to overcome these limitations, a novel robotic radiotherapy system will be developed that can efficiently utilize the full potential of the non-coplanar delivery space to treat the majority of radiotherapy patients. Innovation: The proposed system is highly innovative in the following aspect: 1) Integrated beam orientation and fluence optimization. 2) Significantly more compact linac to allow posterior beams. 3) Flexible field sizes and MLC resolution to efficiently treat most target sizes. 4) Volumetric imaging and real-time IGRT will be implemented. This project is proposed to design the hardware and software platforms materializing such a robotic radiotherapy system. In order to reduce the gantry size, both the linac length and the distance between the source and the MLC need to be significantly reduced. A new 3 MV source has been designed to reduce linac length and provide the required dose rate for treatment. The physical MLC leaf thickness cannot be substantially thinner than 1 mm. To achieve a high MLC resolution at the treatment distance, a spacer is used in CyberKnife between the primary collimator and the MLC, increasing the gantry dimension. This proposed system will eliminate the spacer but vary the focus-to-tumor distances (FTD) to achieve desired field size and MLC resolution. This requires optimization in an enormous solution space, a capacity uniquely demonstrated by the 4? algorithm. Aims: 1a: Build the 3MV linac that can produce 800 cGy/min at 100 cm. 1b. Mount the linac on an industrial robot and test its mechanical robustness. 1c. Integrate a micro multi-leaf collimator (MLC). 2a. Develop a global optimal direct aperture solution for the static intensity modulated radiotherapy (IMRT). 2b. Develop a global volumetric modulated arc therapy (gVMAT) solution. 2c. Develop a navigation algorithm for the robot to travel and deliver the radiation efficiently. 3a. Perform safety and collision model test. 3b. Dosimetry end-to-end testing. 3c. QA test. Impact: Successfully achieving these three aims will provide a prototype to prove the feasibility of the versatile robotic system for radiotherapy. It will be scientifically and clinically significant, positioning the system well for further commercial development.

Public Health Relevance Statement:
Success of the proposed project would lead to the development of a novel radiation therapy device capable of significantly reducing the radiation dose deposited to healthy tissue during cancer treatment. The final clinical system to be developed in Phase II would revolutionize the field of radiation therapy by allowing this precise tumor targeting to be achieved with a quick, flexible robotic system enabling high patient throughput. This system is expected to manage a wide range of diseases and treatment fractions, thus having a broad clinical and commercial impact.

Project Terms:
Algorithms; arm; Automation; Cancer Patient; cancer therapy; Clinic; Clinical; clinical research site; clinically significant; Collimator; commercialization; Competence; Complex; Computer software; cost; cost effective; Deposition; design; Development; Devices; Dimensions; Disease; Dose; Dose-Rate; dosimetry; Eligibility Determination; Engineering; experience; flexibility; flu; Grant; Head and neck structure; Image; image guided radiation therapy; improved; Industrialization; innovation; Intensity-Modulated Radiotherapy; Lead; Length; Location; malignant breast neoplasm; Malignant Female Reproductive System Neoplasm; Malignant neoplasm of gastrointestinal tract; Malignant neoplasm of lung; Maps; Mechanics; Modeling; Neuraxis; Normal tissue morphology; novel; Outcome; Patients; Performance; Phase; Plant Leaves; Positioning Attribute; Problem Solving; prototype; Radiation; Radiation therapy; Radiometry; Reproducibility; Research Personnel; Resolution; Resources; Robot; Robotics; Roentgen Rays; Safety; Site; Small Business Innovation Research Grant; Source; Speed; success; Supervision; System; Techniques; Testing; Thick; Time; time use; Tissues; Travel; Treatment outcome; treatment planning; tumor; Urogenital Cancer