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286 Nanotechnology Imaging Agents or Devices for Improved Detection of Cancer

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:
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 as ideal candidates for imaging and sensing purposes. Further functionalization of these materials 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.

Early detection of cancer is a vital key in the fight against cancer. By the time patients are diagnosed with breast, lung, colon, or ovarian cancer, more than 60% already have hidden or known metastases. For example, more than two thirds of ovarian cancer cases are detected at an advanced stage, and the 5-year survival rate is 40%. However, if this disease is detected and treated at Stage I (when it is still confined to the ovary) the survival rate increases to 90%. Consequently, efforts are currently being made to develop new diagnostic solutions comprising of imaging agents providing for higher spatial resolution.

To accelerate such efforts, the National Cancer Institute (NCI) requests proposals for the development of commercially-viable nanotechnology-based imaging agents 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 imaging agents or devices 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 agents and devices can be used for early imaging/detection of initial onset of disease, or be used as post-treatment monitoring to image/detect recurrence of disease.

Potential relevant imaging agents could include, but are not limited to:

Imaging nanoparticles
Examples: Fluorescent agents (quantum dots, quantum rods, etc.); medical imaging agents (MR, CT, SPECT, PET, etc.); in vivo sensors (FRET sensors, biologically activated systems, etc)

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 (MR, CT, PET, etc.) before, during, and after interventions (resection, chemotherapy, etc.); Novel in vivo sensors to monitor cancer biology-related activities (enzymes, cleaved peptides, etc.).

Imaging agents for intra-operative applications
Examples: Fluorescent, bioactivated imaging agents (quantum dots, quantum rods, etc.) which are applied directly to the tumor site during resection or via systemic routes to delineate tumor cells from normal, healthy tissue and allowing the surgeon to successfully assess the tumor tissue margins.

Potential Applications: Use of novel imaging agents to assure complete tumor resection during the surgery and thus eliminating the need for follow-up surgery due to imperfect identification of tumor margins.

Imaging apparatus or equipment
Examples: Apparatus or equipment incorporating nanotechnology into the final instrument capable of delineating normal tissue from tumor tissue using X-ray, MR, CT, PET modalities.

Potential Applications: Imaging instrumentation with higher performance and lower cost than existing technologies

Proposals may include, but are not limited to, any of the above examples. Given the diversity of potential applications discussed above, submitted proposals should place emphasis on the specific nanotechnology-enabling component of the proposed imaging agent or device.

Phase I activities and expected deliverables:
  • Design describing:
    • 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,
    • Imaging agents and nanoparticles: In vivo small animal efficacy studies.
    • Apparatus and equipment: Small animal imaging studies.
  • 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.
    • Imaging agents and nanoparticles: In vivo animal toxicology studies that can be used for regulatory filing purposes.
    • Apparatus and equipment: Animal imaging studies that can be used for regulatory filing purposes.
  • Submitted IND or IDE application to obtain necessary regulatory approval for clinical validation.

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