Notice Number: NOT-CA-13-011

Key Dates
Release Date: July 18, 2013

Issued by
National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to clarify specific requirements and aspects of the scientific scope of Funding Opportunity Announcement (FOA) PAR-11-150, entitled “Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01),” heretofore referred to as the Quantitative Imaging Network (QIN).

In response to inquiries from prospective applicants, the NCI clarifies the following points pertinent to language in PAR-11-150 that refers to research resources which include, for example, informatics, data archiving, and software tool-sharing requirements.

Therefore, the following text is hereby added to Part 2. Section I. Funding Opportunity Description, 1. Research Objectives, under Specific Goals and Requirements just after the statement "Plans for progressive validation of the components for targeted {of} Phase 1 and 2 trials must also be described."

Resource Areas. Although the primary research emphasis of this FOA is the development and evaluation of methods to support the prediction and/or evaluation of responses to therapy, expanded development of QIN network-wide research sources are necessary for current and future QIN research sites to conduct this research more effectively. Given the expanding scope of resources needed, the specific purpose of this Notice is to add an opportunity for applications to be focused only on supporting QIN network-wide research resources. Applicants who propose such applications should have prior research experience and capability in prediction and/or evaluation of responses to cancer therapy. They should show how the proposed research resources will support comparisons of the performance of related tools and methods for an array of imaging and/or molecular commercially supported imaging modalities, and/or their adoption in clinical trials.

By way of example only, applications may be focused on one or more of the following research resources:

• Development and maintenance of an informatics data sharing infrastructure that should include de-identification, quality control, user specific access control, helpdesk/support services, and hosting services. (Detailed standard operating procedures (SOPs), with appropriately assigned resources to leverage the proposed infrastructure in the context of QIN goals should be provided.)
• Utilization of the DICOM Standard PS 3.15 Annex E guidance on de-identification to ensure retention of all necessary metadata while adhering to all Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) regulations.
• Implementation of QIN-adopted methods for data submission and archival, including Clinical Trials Processor (CTP) software for data collection and National Biomedical Imaging Archive (NBIA) software for hosting the image data.
• Provision of web-based infrastructures to host all related software and statistical tools for clinical decision support and to permit these tools to be evaluated against selected data on the proposed imaging archive, including the use of cloud computing.

All tools and methodology must be open source and open access such that they can be implemented by other members of QIN and the scientific community.

It is anticipated that if several such applications are funded, a federated data archive and tool sharing resource will implemented as a Trans-QIN resource.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Robert J. Nordstrom, Ph.D.
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Telephone: 240-276-5934
Fax: 240-276-7890
Email: [email protected]

James Deye, Ph.D.
Radiation Research Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Telephone: 240-276-5705
Fax: 240-276-5827
Email: [email protected]