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301 Probing Tumor Microenvironment Using In-vivo Nanotechnology-based Sensors

(Fast-Track proposals will not be accepted. Phase II information is provided only for informational purposes to assist Phase I offerors with their long-term strategic planning.)

Number of anticipated awards: 3-5

Budget (total costs): Phase I: $200,000 for 9 months;
Phase II: $1,000,000 for 2 years

It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 7, 2011 by 5 p.m. EST.

Biological fluids and tissue biopsies provide important information with respect to a diagnosis of cancer and to efficacy of its treatment. The collection of both (especially the biopsy) is invasive and can be achieved only in single time points with limited frequency. The analysis of biological fluids (blood, urine), which are easier to collect, do not provide for direct representation of the tumor development. It assesses the status of the tumor only on the basis of biomarkers which are given away by the tumor and release to the biological fluid. The release of these biomarkers and its close correlation to tumor growth varies from organ to organ and its kinetics is not well understood.

On the other hand, ability to monitor tumor microenvironment directly in vivo, in close proximity to the tumor site, will facilitate for a significant improvement in the collection of data (metabolite concentrations, biomarkers, enzymatic activity) associated with tumor growth and its behavior under treatment. It will also contribute to advancing out understanding of metastasis. Nanotechnology allows for the design and manufacture of complex munti-functional particles and devices which could yield temporal data for these important parameters in vivo. This could be achieved in several ways: 1) through the development of nanoparticles with surfaces or biological coatings which recognize parameters associated with tumor microenvironment where tumor-targeted particles are introduced systematically; 2) through the design of implantable biochemical sensors which can collect data over the extended period of time; 3) through the design of circulating nano-sensors which collect data while traveling in bloodstream and then are excreted from the body for further evaluation.

To accelerate such efforts, the National Cancer Institute (NCI) requests proposals for the development of commercially-viable nanotechnology-based diagnostic platforms capable of monitoring tumor microenvironment in vivo.

Project Goals:
The goal of the project is to develop nano-enabled in-vivo diagnostic platforms that can provide increased sensitivity and specificity in detecting cancer or cancer metastasis or monitoring effectiveness of the treatment in pre-clinical animal models of cancer and/or in human patients. These capabilities will offer clinicians a way to maximize opportunities for early disease recognition and produce.

Potential relevant sensing nanoplatforms could include, but are not limited to:

Nano-enabled Sensing Platforms for In vivo Applications

Examples: Several different design modalities can be considered: 1) use of nanoparticles which are introduced systematically or locally and possess surfaces or biological coatings which recognize parameters associated with tumor microenvironment and report their chance (through the change of electrical, optical, magnetic signal); 2) use of biochemical sensors which are implanted and can collect data over the extended period of time; 3) use of systemically introduced nanoparticles or nanodevices which collect the data and subsequently are excreted for further evaluation.

Potential Applications: Diagnosis of cancer or cancer metastasis or long-term monitoring of treatment effectiveness based on biochemical markers or CTCs or other physiological indicators such as pH or oxygen level.

Given the diversity of potential applications discussed above, submitted proposals should place emphasis on the specific nanotechnology-enabling component of the proposed platform.

Phase I Activities and Expected Deliverables
  • Design describing:
    • unique in-vivo sensing capabilities enabled by nanotechnology.
    • proof of concept experiments.
    • benchmarking experiments against conventional methodologies.
  • First-stage validation of design in relevant preclinical samples,

    • Demonstrate 1) the recognition of relevant clinical biomarkers or other tumor microenvironment indicators by nanoparticles or nanodevices incubated in blood, urine, or other biological fluids in vitro at varied concentrations and concentration profiles, and 2) isolation of nanoparticles from the biological fluid.
  • Successful completion of benchmarking experiments demonstrating a minimum of 5x improvement against conventional methodologies.

Phase II Activities and Expected Deliverables
  • Second-stage validation of design for potential clinical adaptation.
    • Demonstrate the recognition of relevant clinical biomarkers or other tumor microenvironment indicators by nanoparticles or nanodevices in relevant animals models including large animals.
  • Systematic study of sensitivity and specificity of the sensor platform in pre-clinical or clinical samples and demonstrate reproducibility.
  • Collect data from a statistically significant number of animals or patients in preparation for an IDE application.
  • Submitted IDE application to obtain necessary regulatory approval for clinical validation.

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