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252 Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer

Number of anticipated awards: 3-5
(Fast-Track proposals will be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $1,000,000

The deadline for receipt of all contract proposals submitted in response to this solicitation is: 5:00 p.m. Eastern Standard Time Monday, November 5, 2007

Nanotechnology involves the design, synthesis, and manipulation of materials at the nanoscale to take advantage of novel material properties (e.g., large surface to volume ratio, increased conductivity, enhanced imaging contrast, etc.) that are not normally present in conventional bulk length scales. These properties render nanomaterials ideal candidates for imaging, sensing, and detecting purposes. Further functionalization can be achieved by conjugating biological ligands (e.g., oligonucleotides, short peptide sequences, antibodies, etc.) that can serve to achieve specific targeting of cells/tissues/organs or specific capturing of genomic/proteomic candidate biomarkers.

For several types of cancer, the primary cause of poor survival is late detection, most often after the disease has spread to distant sites. For example, most melanomas that are found without evidence of metastasis can be cured with surgical resection. In contrast, for patients with advanced or metastatic melanoma, the prognosis is poor (a 5-year survival of 5-10%). Consequently, efforts are currently being made to develop new diagnostic solutions comprising imaging and/or monitoring of prognostic biomarkers.

To accelerate such efforts, the National Cancer Institute (NCI) requests proposals for the development of commercially-viable nanotechnology-based imaging agents and/or sensing platforms that will ultimately assist and improve current clinical protocols of cancer detection and diagnosis.

Project goals:

The goal of the project is to develop nano-enabled platforms that can provide increased resolution both spatially, and more importantly, temporally, in detecting cancer that would ultimately offer clinicians a way to maximize the chance of positive clinical prognosis. The platforms can be used for early detection/imaging of initial onset of disease, or be used as post-treatment monitoring to detect/image recurrence of disease. Strategies can also include screening assays that provide a better mechanistic understanding of metastasis which can help develop better therapies and further improve patient outcome. As current drug development continues to rely mainly on reductions in overall size of tumors, many validated compounds may not work on metastatic disease. Novel imaging and sensing diagnostic nanoplatforms could also be used, in a preclinical setting, both for high-throughput screening assays to locate new metastasis-directed compounds and for validating the new compounds in vitro, in situ, and ultimately, in vivo.

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

Imaging and Sensing Nanoparticles

• Examples: Fluorescent agents (e.g., quantum dots, quantum rods); medical imaging agents (e.g., MR, CT, SPECT, PET); in vivo sensors (e.g., FRET sensors, biologically-activated systems).
• Potential Applications: Use of agents as secondary-tags to improve existing in vitro/ex vivo assays; Detecting smaller lesions and/or better delineation of tumor margins with traditional clinical imaging modalities (e.g., MR, CT, PET) before, during, and after interventions (e.g., resection, chemotherapy); Novel in vivo sensors to monitor cancer biology-related activities (e.g., enzymes, cleaved peptides).

Nano-enabled Sensing Platforms

• Examples: Use of functionalized nanomaterials (e.g., nanowires, nanotubes, nano-cantilevers) to build sensing platforms with optical or electrical output.
• Potential Applications: Novel platforms that would enhance sensitivity/specificity of existing candidate biomarker detection and validation; Sensing of tumor metastasis and/or recurrence post-treatment.

High-throughput Screening Nanoplatforms

• Examples: Single or combinations of nanotechnologies (e.g., nanopatterning, imaging agent, sensing platform, microfluidics) for assay development.
• Applications: Locating novel cancer biomarkers that may be undetectable using traditional assays; detecting cellular changes using nano-sensors to screen for novel therapeutic agents.

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:
  • Sensing/imaging methodology
  • Unique spatial/temporal capabilities enabled by nanotechnology
  • Proof of concept experiments
  • Benchmarking experiments against conventional methodologies
• First-stage validation of design in relevant preclinical samples as listed below,
  • Medical imaging agents: In vivo small animal efficacy studies
  • Sensing platforms: Candidate biomarkers in serum-free samples
  • High-throughput imaging and screening assays: Non-primary cell lines and/or tissue samples
• Successful completion of benchmarking experiments demonstrating a minimum of 2x improvement against conventional methodologies.

Phase II activities and expected deliverables:

• Second-stage validation of design for potential clinical adaptation:
  • Medical imaging agents: In vivo small animal toxicology studies that can be used for regulatory filing purposes
  • Sensing platforms: Candidate biomarkers in patient samples
  • High-throughput imaging and screening assays: primary cells and/or tissues obtained from patients
• Submitted IDE application to obtain necessary regulatory approval for clinical validation.