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Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (U01 Clinical Trial Required)

National Institutes of Health

This funding opportunity aims to support high risk clinical trials for 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. Structural and functional aspects, including visualizing dynamic elements, are important to developing 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 must be proposed to develop, advance, or test 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 funding opportunity supports a cooperative agreement between an NIDCD Project Scientist and an Investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has potentially higher risks to participants.

These investigator-initiated clinical trials are perceived to benefit from close interaction, oversight, and guidance resulting from a cooperative agreement.

Only one clinical trial may be proposed per application submitted to this funding opportunity.

Low risk clinical trials not meeting any of the criteria above are referred to the companion In Vivo High-Resolution Imaging for Inner Ear Visualization (R01 - Clinical Trial Optional) RFA-DC-24-004 .

Investigators are strongly encouraged to contact the scientific/research contact, prior to submission, to ensure this is the correct NOFO for their proposed research.

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-24-005 Expiration Date New Date June 04, 2025 per issuance of NOT-DC-24-031 . (Original Expiration Date: February 04, 2025 )