Early Detection and Monitoring of Cardiac Injury Due to Cardiotoxicity
Cardiotoxicity is increasingly recognized as a significant challenge to many existing therapies and as a potential barrier to the development of new therapies. For example, despite improved survival from cancer, chemotherapy-induced cardiotoxicity has emerged as a significant problem. Cardiovascular complication, particularly heart failure, is an important cause of morbidity and mortality among cancer survivors. In small studies, cardioprotective strategies against cancer therapy-induced cardiac dysfunction are effective if implemented early at the subclinical phase. However, detection of the frequency of subclinical disease and subsequent ability to protect against further functional decline are limited by inadequacy of current technologies to accurately assess and monitor changes in cardiac structure and function. Novel non-invasive strategies that detect early subclinical changes in cardiac structure, function, and/or tissue are needed to improve detection and monitoring of cardiac injury in order to improve cardioprotection and effectiveness of cancer therapeutics or other toxic exposure. Studies that demonstrate increased sensitivity and precision of existing or enhanced imaging technologies with respect to normal and altered cardiac structure, function, energetics, and metabolism are sought. Pre-clinical or patient studies using molecular changes or biomarkers to enhance early detection of cardiac derangements are also responsive.
The goal of this initiative is to encourage the development of innovative methods to detect and monitor cancer therapy-induced cardiac injury as early as possible through minimally invasive means. Early monitoring of cardiac injury will enhance both cardiac safety and treatment efficacy of cancer therapies.
Phase I Activities and Expected Deliverables
Phase I activities include proof-of-concept studies to demonstrate the feasibility of the method that will be fully developed in the Phase II. Examples of Phase I research and expected deliverables may include, but are not limited to:
? Design, testing, and initial in vivo validation of imaging methods or probes capable of assessing subclinical myocardial injury by cardiac MR, PET, or x-ray based imaging
? Identification, selection, and initial testing of biomarker-based monitoring methods of cardiac injury, specifically aimed for cardiac injury due to chemotherapy
? Studies to demonstrate innovative advances in ultrasound-based methods, including echocardiography, to improve sensitivity and resolution in order to assess early cardiac structural or functional changes
Phase II Activities and Expected Deliverables
Phase II activities are expected to include full development of the method whose feasibility was successfully demonstrated in Phase I, including additional validation in order to apply for regulatory approval and attract funding from industry. A detailed report of interactions with the Food and Drug Administration (FDA) identifying the requirements for regulatory clearance or approval of the method is needed. Examples of Phase II activities may include, but are not limited to:
? Development and validation of imaging methods to assess subclinical myocardial injury by cardiac MR, PET, or x-ray based imaging
? Validation of biomarker-based monitoring methods of cardiac injury, specifically aimed for cardiac injury due to chemotherapy
? Development of novel ultrasound-based methods, including echocardiography, to assess early cardiac structural or functional changes
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is to conduct and support biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of alcohol abuse and the treatment of alcoholism, and to conduct a study of alternative approaches for alcoholism and alcohol abuse treatment and rehabilitation.
This solicitation invites proposals in the following area.
- Agency: Department of Health and Human Services,Department of Health and Human Services
- Program: SBIR
- Phase: Phase I
- Release Date: July 24, 2015
- Open Date: July 24, 2015
- Close Date: October 16, 2015
- URL: https://sbir.nih.gov/sites/default/files/PHS2016-1.pdf