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Contract Topics
258 Innovative Devices to Protect Radiosensitive Organs and Structures During Radiation Therapy
Number of anticipated awards: 3
(Fast-Track proposals will be accepted.)
Budget (total costs): Phase I: $200,000;
Phase II: $1,000,000
(Note: Proposals with budgets exceeding the above amounts will be returned without review. Phase I project periods may last a maximum of 9 months. Proposals with durations exceeding 9 months will be returned without review.)
The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.
Summary:
Radiation therapy is an important tool in the cancer treatment arsenal. More than one million patients undergo radiation therapy in the US each year. Recent improvements in radiation therapy instrumentation increased the clinical utility of this treatment modality. Despite significant progress, there are still situations where patient/organ motion is limiting the dose that can be safely delivered to the tumor without damaging adjacent radiosensitive organs such as bladder, heart, spinal cord and others. There have been significant recent advances in this area, examples of which include development of implantable markers and electromagnetic localization systems, introduction of respiratory gating, advances in image-guided radiation therapy, growth in availability of proton/heavy ion radiotherapy, brachytherapy, and others. However, in certain clinical situations damage to the adjacent tissues, and resulting complications, could be further reduced and therapy efficacy could be enhanced, if better knowledge of radiation dose distribution could be obtained and organ motion during the radiation delivery could be better controlled. This contract topic seeks to stimulate research, development, and commercialization of innovative devices designed to protect radiosensitive organs and structures during radiation delivery.
It is expected that the proposed innovation is driven by clinical practice. Therefore, in addition to standard proposal components; the contract proposal must contain specific discussion of:
- Evidence of an existing clinical problem which is addressed by the proposed method.
- Analysis of competitive methods to address the same problem and explanation of competitive technical advantages of proposed system.
- Quantitative estimate of the number of patient cases where the strategy will help to deliver better result per typical clinical site. This evaluation should be supported by literature, radiation oncologists, radiologist, medical physicist, or other qualified specialist.
Project Goals:
The short-term goal of the project is to perform proof-of-principle technical feasibility demonstration of innovative strategy for protection of critical organs and structures through methods or procedures enacted prior to, during, or following the radiation delivery. These strategies may include, but are not limited to innovative devices, methods, phantoms, software, imaging systems, etc to assist in this goal. The long-term goal of the project is to generate scientific evidence regarding the safety and efficacy of the method and to bring the strategy to the clinic and to the market.
Phase I activities should support the technical feasibility of the innovative approach. Specific activities and deliverables during Phase I should include:
- Design of a prototype system.
- Development or procurement of an appropriate phantom necessary to evaluate the performance of the proposed system.
- Validation of the prototype system with the phantom.
Phase II activities and expected deliverables:
Phase II activities should support introduction of the device into clinical practice. All Phase II or Fast-track proposals must contain a section entitled "Regulatory Plan" demonstrating an understanding of the regulatory requirements for clearing the device through the FDA, company's plan in meeting the requirements, and explanation of how the proposed work helps to meet these requirements. Where cooperation of other equipment manufacturers is critical for implementation of proposed methodology, company should provide evidence of such cooperation (through partnering arrangement, collaboration, or letters of intent).
Specific activities and deliverables during Phase II should include:
- Design of clinic-ready device using FDA-compliant design process.
- Scientific studies of system performance as required by the FDA for submitting IDE, 510(k), PMA, or other appropriate regulatory pathway. (Studies may include phantom testing, animal testing, clinical testing, etc.).
- Production of a clinic-ready system and R&D activities to support integration of such system in clinical practice.
- Submission of scientific publication regarding system performance oriented at the end user (radiation oncologist, medical physicist, etc.).
