The long-term goal of this initiative is to determine the appropriate use of imaging and fluid-based tumor monitoring (liquid biopsy) assays to monitor therapy during active cancer treatment of patients. The specific combination of assays will likely be dependent on the molecular characteristics of the disease and the assay detection limits. The precise application of a given combination of imaging and liquid biopsy assay should result in the determination of response or emergence of tumor treatment resistance at the earliest, unequivocal time point.
Appropriate cancer treatment settings include:
- Clinical trials in which patients are undergoing active treatment for first recurrence of a cancer (e.g., breast, prostate, colorectal, and melanoma) with effective second-line treatments and are being monitored for treatment success, failure, or recurrence.
- First-line therapy with aggressive or advanced disease.
- Retrospective data collection and analysis from studies currently using imaging and fluid-based treatment response monitoring.
Any proposed clinical study must be able to be completed in the 5-year funding timeframe.
This FOA is not designed to support research for long-term post-treatment surveillance in patients where treatment has been curative, or in screening settings for early detection. It also is not designed to support pre-clinical development and testing of imaging agents/modalities or fluid-based tumor monitoring (liquid biopsy) assays.
For this initiative, imaging is defined as any in vivo molecular or functional clinical imaging modality. Fluid-based tumor monitoring (liquid biopsy) assay is defined as an assay such as circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), circulating RNA, exosomes, etc., that are isolated from a bodily fluid and quantified. Importantly, the chosen liquid biopsy and imaging method must already be developed and validated (or in final validation) for clinical application. This initiative is not intended to support the development of novel imaging or liquid biopsy methods.
Specific Areas of Research Interest:
Research questions appropriate for this initiative include, but are not limited to:
- Do imaging and fluid-based tumor monitoring (liquid biopsy) results correlate during therapy or after treatment?
- What is the minimal fluid-based monitoring (liquid biopsy) change that corresponds to a change detected by imaging during treatment?
- Are there cancer types where tumor response or emergence of resistance is detectable by imaging earlier than changes in fluid-based tumor monitoring (liquid biopsy) or vice versa?
- Are combinations of fluid-based tumor monitoring (liquid biopsy) and imaging methodologies specific for a specific cancer or therapy type?
- Are there circumstances where a combination of fluid-based tumor monitoring (liquid biopsy) and an imaging assay is more powerful than either assay alone?
Applications submitted to this FOA should by supported by:
- Justification the choice of patient population.
- Evidence that the necessary clinical trial and patient population will be available to the investigators.
- Demonstration of Food and Drug Administration (FDA) Investigational New Drug (IND)/Investigational Device Exemption (IDE) availability (where required) of imaging methods or agents and fluid-based tumor monitoring assays.
- Evidence that the clinical trial will be able to be completed in the 5-year funding time frame.
- Statistical rationale that the correlations between imaging and fluid-based tumor monitoring results will be clinically meaningful.
Applications that do not provide adequate information that supports the items above will not be considered for funding. Applications will also not be considered for funding if they include: pre-clinical development of imaging agents/modalities or fluid-based tumor monitoring (liquid biopsy) assays; and/or clinical trials for long-term post-treatment surveillance in patients where treatment has been curative, or in screening settings for early detection.
Deadlines: standard dates and standard AIDS dates apply
Filed Under: Funding Opportunities