Clinical Translation of Activated Optical Fluorescence Methods and Technologies for Sensitive Cancer Detection in Vivo (R01 Clinical Trial Optional)

Organization
NCI
Type
NIH
Application or LOI Due Date
01-10-2021
Number
PAR-20-295
Comments
LOI due 30 days prior to the application due date. Application Due Date(s) February 10, 2021; October 13, 2021
Brief Description

The purpose of this Funding Opportunity Announcement (FOA) is to bring a highly sensitive imaging technology capable of detecting very small (1-3 mm3) tumors in vivo to clinical utility. Through this FOA, the National Cancer Institute (NCI) solicits innovative concepts that propose a path to clinical validation for in vivo ‘intelligent’ or activated optical fluorescence agents or probes with previously demonstrated capabilities for the detection of small tumors.

Current imaging techniques are in use for non-invasive cancer detection, but clinical methods are limited to detecting masses several millimeters to centimeters in size. To image small primary or metastatic tumor sites composed of 106 -107 cells, imaging sensitivity must be improved. This can be achieved without significant hardware advances by improving the contrast between diseased and healthy tissue captured in the image. Thus, there is a clinical need for techniques that improve image contrast between tumors and surrounding normal tissue. There are several novel optical fluorescence methods that rely on the use of specialized agents that are activated when coupled to a tumor target. These activated agents dramatically increase the contrast between small tumor cell masses and surrounding tissue. Efforts to develop activated fluorescence imaging agents have been ongoing for over a decade. These developmental successes now need to be translated for clinical use.

This FOA thus supports translation of novel activated optical fluorescence agents for sensitive cancer detection in vivo. Clinical translation and validation should be the primary goals of the proposed research. The bulk of the proposed research must focus on translating improvements in imaging sensitivity to a clinical environment with the goal of demonstrating that tumor cell aggregates on the order of 1 mm 3 in volume can be visualized in vivo. However, minimal research toward development of the probe in preparation for clinical validation will be accepted under this FOA. This FOA thus supports translation of already developed technologies for small tumor detection in vivo. It is not intended to support continued development of novel agents or preclinical studies.