Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will NOT be accepted.
Number of anticipated awards: 3-5 Budget (total costs, per award):
Phase I: up to $400,000 for up to 9 months Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
Oncologists are reliant on patient imaging to support clinical decision making and treatment planning for many types of cancer. Therefore, there is a constant need to develop, optimize, and validate new quantitative imaging and dosimetry tools and methods to improve and better inform diagnosis and treatment.
Phantoms are widely used in medical imaging for instrument tuning, quality control, and scientific research. Traditional phantoms are vessels manufactured from man-made materials (e.g., acrylic, resins, etc.) that are filled with solutions containing an agent or tracer compound used in a modality-specific imaging application (e.g., MRI, SPECT, CT, PET systems). Due to their bulk, phantoms are typically not concurrently scanned with the patient.
Recent technologies in the tissue engineering and biomimetics sector offer opportunities for construction of phantoms from tissue-equivalent materials with formulations that better represent the unique characteristics of organs commonly afflicted with cancers (e.g., brain, liver, breast, skin, bone, pancreas). Unique physical and chemical features can be engineered into tissue biomimetic systems with high precision, such as calibrated patches, zones, or gradients of varying stiffness, density, oxygenation, pH, temperature, etc. Bio-engineered matrixes may also incorporate fiducials and imaging agent(s) at known concentrations that can serve as a standardized reference from which quantitative dosimetry data in a tissue-equivalent context can be compared to data obtained by imaging these agents in the patient. Proper calibration and inter-comparison of scanners and imaging devices located in different institutions is crucial for clinical research rigor.
Project Goals
The goal of this concept is to stimulate growth in development of scalable quantitative tissue-equivalent technologies that would benefit patients who rely on cancer imaging modalities for diagnosis, dosimetry, and treatment. By prompting availability of new commercialized “smart-phantoms,” the solicitation has potential to catalyze scientific discovery in the broader cancer community wherein these commercialized devices could be used by researchers traditionally without access to tissue engineering biomimetic technologies. Small business development of Quantitative Biomimetic Phantoms (QBP) as organ-specific surrogates have potential to accelerate computational testing of sequences and algorithms to derive new quantitative radiomic and dosimetric data from cancer patients.
The activities that fall within the scope of this solicitation include development and application of QBP devices that represent or simulate specific tissue types or organ sites. QBP devices are to provide the means to objectively detect, measure, and spatially resolve imaging probe(s) in the context of the QBP device’s tissue-equivalent environment(s) using either single- or multi-modal cancer imaging scanner systems. Examples of appropriate activities include pre-clinical feasibility and durability studies of the QBP device as a calibrated quantitative analysis tool that can improve quantitative accuracy and precision in imaging data obtained from the corresponding tissue type(s) or organ site(s) the QBP is intended to simulate. Phase I activities should generate data to confirm the feasibility and potential of the QBP technology(ies) to provide quantitative measurements of probes from cancer imaging systems.
Phase I Activities and Deliverables
• Define the cancer imaging modality or application(s) the QBP device(s) or combined device-computational approaches addresses (such as MRI, SPECT, CT, PET). Multimodal applications are suitable, but not required;
• Define the tissue type(s) or organ site(s) the QBP device is intended to simulate. Offerors may propose to deliver a QBP device that represents only one distinct tissue/organ site, or one that has representation of multiple distinct tissues or organs;
• Define the key tissue type or organ specific physical characteristics the QBP device is intended to simulate;
• Generate proof-of-concept data that demonstrate the means to objectively detect, measure, and spatially resolve imaging probe(s) in the context of the QBP device’s tissue-equivalent environment(s) using the respective cancer imaging scanner(s);
• Demonstrate feasibility of the QBP device as a calibrated quantitative analysis tool to improve quantitative accuracy and precision in imaging and/or dosimetry data obtained from the corresponding tissue type(s) or organ site(s) the QBP is intended to simulate.
o Offerors should specify quantitative technical and commercially-relevant milestones, that can be used to evaluate the success of the tool or technology being developed. Offerors should also provide appropriate justification relevant to both the development and commercialization of these technologies.
o Quantitative milestones may be relative metrics (e.g. compared to benchmarks, assays and/or algorithms to detect and measure the probe analyte), and/or absolute metrics (e.g. minimum level of detection).
Phase II Activities and Deliverables
• Demonstrate reliability, robustness, and usability in clinical and/or basic cancer research, dosimetry, and/or treatment planning;
• Demonstrate system performance and functionality against commercially relevant quantitative milestones. o Offerors should specify quantitative technical and commercially-relevant milestones, that can be used to
evaluate the success of the tool or technology being developed;
o Offerors should also provide appropriate justification relevant to both the development and scalable commercialization of these technologies;
o Quantitative assessment milestones may be relative metrics (e.g. compared to benchmarks, assays and/or algorithms to detect and measure the probe analyte), and/or absolute metrics (e.g. minimum level of detection);
• Demonstrate rigor and reproducibility in benchmark experiments using relevant cancer imaging scanners or systems;
• Demonstrate the QBP device and associated computational tools provide a calibrated and quantitative reference to assess radiometric characteristics relevant to cancer imaging and/or dosimetry of the tissue type(s) or organ site(s) the QBP device is intended to simulate;
• Show feasibility to be scaled up at a price point that is compatible with market success and widespread adoption by the cancer research community;
• In the first year of the contract, provide the Program and Contract officers with a letter(s) of commercial interest;
• In the second year of the contract, provide the Program and Contract officers with a letter(s) of commercial commitment
