383 Smart, Multi-Core Biopsy Needle
Fast track proposals will be accepted.
Number of anticipated awards: 2-3
Budget (total costs, per award): Phase I: up to $300,000 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.
Tumor recurrence or resistance to treatment often arises due to the underlying genomic or phenotypic heterogeneity of cancer cells and the microenvironment. Tissue cores taken by needle biopsies are used to provide diagnostic and prognostic information about solid tumors. Currently, if multiple cores are needed from a solid tumor, additional needles must be inserted at different locations in the tumor. Problems with this approach include the need for multiple injections, lack of data on positioning and physical parameters (e.g. pH and rigidity) within the tumor, and absence of retaining the layout of the tissue when the tissue is extracted from the needle. The current method lacks capability for measuring physical and biological characteristics like pH, oxygenation, rigidity, and tissue integrity. The goal of this contract solicitation is to support the development and engineering of a smart, multi-core biopsy needle that will allow for simultaneous sampling of a tumor while maintaining and elucidating geographical and physical information, ultimately to gain a better understanding of intra-tumor heterogeneity. The dimensions of the biopsy needles need to be comparable with current methods of aspiration or surgical incision biopsies for specific tumor types, and these new smart devices need to incorporate components to: 1) collect biopsies from multiple tumor cores in a biologically and clinically feasible manner, 2) identify specific locations of the biopsies
relative to the tumor and one another, 3) maintain physical and positioning characteristics of tumor on the extracted tissue, and 4) be adaptable for use under current image-guided biopsy or needle tracking practices.
The development and engineering of a smart, multi-core biopsy needle would allow for simultaneous extraction of tumor core biopsies with 3D positioning [similar to global positioning system technologies (GPS)] and physical parameter data and maintenance of tumor tissue integrity. The biopsy needle must be adaptable for use with image-guidance approaches that are currently used in clinical practice. In the short-term, the project will help provide additional information that can be utilized to elucidate the biological complexity of intra-tumor heterogeneity. In the long-term, it is envisioned that the pH and other physical parameter data (e.g. stiffness) of a tumor across multiple regions could be probed and mapped to the spatial positioning of cancer cells and these data integrated with genotypic and phenotypic data of cancer and stromal cells. Ultimately, the project will have an impact on our understanding of tumor heterogeneity and help guide clinical decisions in designing the course of cancer therapy by obtaining live, intact tumor tissue simultaneously from multiple regions of a solid tumor.
Issues with existing approaches of aspiration and incision biopsies are the need for multiple injections, lack of data on positioning and physical parameters (e.g. pH or rigidity) within the tumor, and absence of retaining the layout of the tissue when the tissue is extracted from the needle. These issues lead to the unmet need addressed with this project, which is the ability to obtain positioning and pH data while maintaining the layout of a tumor from a single biopsy. Activities designed to address this unmet need will be supported, including development of a biopsy needle that has simultaneous multiple core sampling capability. All needles will be required to have positioning and pH sensing capabilities and material coating to allow for maintaining the layout of the tumor once deposited onto a slide or similar platform. The smart, multi-core biopsy needle will also have the capability to be used with current image-guided mechanisms, such as CT, MR, or ultrasound that are often used for obtaining biopsies. The GPS capable smart needle will allow for 3D spatial mapping of the tumor after the tumor is extracted, whereas the image-guided mechanisms are used to guide the needle location during biopsy. This project will be focused on supporting development and engineering of the biopsy needle, and it will not support development of image-guidance technologies alone.
Phase I Activities and Deliverables
• Design and manufacture a smart, multi-core needle device with the following features: o Multiple needles that extract radially from a single, traditional biopsy needle once positioned in a tumor (or other innovative methods to collect multiple cores in a clinically and biologically feasible manner);
o Global positioning system along each of the needles within the tumor to allow for 3D spatial mapping of the tumor;
o Sensors to monitor pH along each of the needles within the tumor (and other physical parameters where possible such as tissue stiffness or rigidity);
o Material coating of the needles (or other innovative methods) to allow for maintaining the layout of the tumor once deposited onto a slide or similar platform;
o Does not significantly damage, change tissue biology, or cause excessive bleeding in regions surrounding the needle placement site;
o Adaptability for use with existing image-guided needle placement methods and needle biopsy procedures.
• Identify the tumor type for which the needle will be developed with adequate justification.
• Specify biopsy needle gauges, spacing and other characteristics for the multi-core biopsy needle that will be developed with adequate justification.
• Show preliminary proof-of-concept of the sensor-guided biopsy in a tumor model (engineered phantom or appropriate animal model) to demonstrate the required design and manufacturing features have been achieved.
• Produce written methodology for the sensor manufacturing with quality assurance and control measures using the Standard Operating Procedure (SOP) template.
Phase II Activities and Deliverables
• Optimize the smart, multi-core biopsy needle design and performance for a clinical setting and refine the manufacturing process.
• Show the feasibility of this novel technique to complement current biopsy procedures.
• Demonstrate the performance of the device as designed and intended in fit-for-purpose studies in relevant large animal models.
• Obtain sufficient animal safety data in preparation for 510(K) or IDE application with the FDA.