This purpose of this Funding Opportunity Announcement (FOA) is to provide a mechanism of support to research organizations interested in clinically translating already optimized quantitative imaging software tools capable of measuring or predicting the response of cancer to clinical therapies, or in translating imaging software tools for planning and validating radiation therapy treatment strategies in clinical trials. The quantitative tools must have been developed and optimized during a performance period in the Quantitative Imaging Network (QIN) or under other separate funding. The proposed research effort should be an extension of the research that successfully completed the tasks of developing and optimizing the chosen software tools or data collection methods intended to facilitate clinical decision making during clinical trials. This FOA is intended to support the efforts of validating those tools in prospective multi-site clinical trials in order to test software tool performance and to demonstrate that the tool can be integrated into clinical workflow with a minimum of disruption.
The goal of quantitative imaging (QI) is to create the condition where clinical imaging devices behave as measuring instruments, providing clinicians with reliable and reproducible numeric (i.e. quantitative) information to predict or measure the health status of patients, or to plan treatment strategies. The primary goal of this FOA, then, is to enhance the value of QI in clinical trials for treatment planning, prediction and/or measurement of response to therapy. This can be accomplished by creating and validating state-of-the-art open source software algorithms, data collection and data processing protocols, and/or treatment planning guidelines to extract quantitative information from clinical images where the measurement bias and variance that can exist across imaging platforms has been reduced.
Projects proposed for this FOA are expected to advance QI methods to reduce the bias and variance in imaging platforms used in clinical trials, to create methods for extracting reliable and reproducible quantitative measurements from clinical images and/or to improve treatment planning during clinical trials. The requirements for testing QI approaches in both single and multisite research settings have been addressed at recent NCI-supported workshops and in numerous QIN-related publications, QIN progress reports, and QIN working group documents. For this FOA, the applicants are strongly urged to be familiar with the published research progress to date from the QIN and other research groups. For details, see the following links:
Current or former QIN members who submit to this FOA with an interest in continuing their research objectives as outlined in their previous application are encouraged to submit a renewal of their previous research. If, on the other hand, the current of former QIN member is considering a different application of an existing tool or method (e.g. a different organ site) where minimal development will be required, that member may submit a new application to this FOA. If the QIN member is considering specific aims and research activities that represent a completely new research direction, then application must be made through PAR-18-248. Applicants without past support from any FOAs relating to the Quantitative Imaging Network program but with developed and optimized clinical software tools for decision support in cancer clinical trials may submit to this FOA as a new application to validate and incorporate the candidate tools in multisite clinical trials. This will not only validate the software tool or method in the clinical environment, but it will also show how the software tool or method integrates into clinical workflow.
The specific objective for the research supported by this announcement is to validate and clinically test the software tools and/or methods previously developed by the applicant. The development and optimization may have been done as a member of the QIN or under separate support. Only minimal development and optimization of tools and/or methods will be permitted in this R01 effort. Such additional development and optimization activities include, but are not necessarily limited to:
- Participation in software challenges, where tools are tested against a standard data set to determine optimized performance,
- Transposing a tool or method optimized for one cancer problem to another type of cancer or cancer within a different organ site,
- Inclusion of a tool or method into a pipeline of tools.
Validation of optimized software tools must be the primary goal of this research effort. During this project, investigators may initially use retrospective clinical trial data for tasks such as testing and demonstrating utility of the software tool across vendor platforms. Eventually, however, one or more prospective multisite clinical trials must be selected as the venue for clinical trial validation of tool performance. Not only will the tool(s) be validated, but the challenges of incorporating the tool(s) into a clinical workflow environment can be addressed.
Note: this FOA will not support any clinical trials. It will, however, support the cost of obtaining imaging and metadata from existing clinical trials as needed to validate QI tools and methods. When tested in clinical trials, software tools and methods being validated can only be a secondary measure or prediction of response to therapy, and will not be used as (nor will they interfere with) standard of care in any clinical trial.
Deadlines: standard dates and standard AIDS dates apply
Filed Under: Funding Opportunities