Trialect

Active

In Vivo High-Resolution Imaging for Inner Ear Visualization (R01 Clinical Trial optional)

National Institutes of Health

This funding opportunity aims to support the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Both structural and functional aspects, including visualizing dynamic elements are important to the development of new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Research supported in response to this funding opportunity is expected to significantly advance the ability to visualize auditory and vestibular components, such as hair cells, otoliths, membranes, ions, and vasculature, in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multidisciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans and intermediate studies in mammalian animal models may be proposed to develop or advance the needed technology. Any intermediate studies must articulate a clear path of the proposed methodology to application in awake humans or define the limitations and the usefulness in anesthetized humans.

This notice of funding opportunity announcement (NOFO) also supports investigator initiated low-risk clinical trials addressing the development or improvement of human in vivo structural and functional imaging technologies. Clinical trials must meet ALL the following criteria: meet the budget limits of this NOFO, not require FDA oversight, not be an NIH-defined Phase III Clinical Trial, have low risks to subjects, and intend to gather scientific data/evidence to inform subsequent studies. This NOFO also supports low-risk trials determined to be Basic Experimental Studies with Humans ( BESH ). These studies fall within the NIH definition of a clinical trial and meet the definition of basic research. It is advisable that only one clinical trial be proposed in each application. High-risk clinical trials not meeting all the criteria above are referred to the companion U01 Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (Clinical Trial required) NOFO RFA-DC-24-005 .

Deadlines:

Letter of Intent Due Date(s): January 01, 2024; May 03, 2024; September 01, 2024; January 03, 2025
Application Due Dates: Feb. 1, 2024; June 3, 2024; Oct 1, 2024; Jun 3, 2025

RFA-DC-24-004 Expiration Date New Date June 04, 2025 per issuance of NOT-DC-24-030 . (Original Expiration Date: February 04, 2025 )