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Fluorescence Optic Fiber Stereotactic Needle Ratiometer for Breast Tumor Diagnosis.

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Annual rept. 23 Sep 95-22 Sep 96,

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Activities during the second year were still restricted to gaining head start knowledge of the intended instrument from the development of a similar instrument for another project. an aerodigestive cancer diagnosis clinical study at Memorial Sloan-Kettering MSK. An extension has been granted and a second extension will be requested based on advice from the reviewers at the recent site visit. Patient trials could not be started with just the approval from the Institutional Review Board IRB of Mass. Gen. Hosp., but require an Investigational Device Exemption IDE from FDA for this Phase I feasibility study. This was determined from the Significant Risk ruling by FDA shortly after the award of the Contract which also halted the the Phase II MSK study, both pending an IDE. The Sponsor has engaged the services of an experienced regulatory compliance consultant in drafting our IDE applications. Armed with recent favorable findings from our animal safety studies, the Phase II IDE application is soon to be filed followed by the Phase II application to permit the clinical trials for the device assembled under this contract. IDE approval is expected in 2097. In the interim, the device will be assembled, and the range finding data will begin to be collected in vitro on excised tissue. Preliminary baseline data already has been collected on breast tissue fat, ductile, etc. using related spectral fluorescence devices in order to develop the algorithm for data analysis. This work will be discussed.

Subject Categories:

  • Anatomy and Physiology
  • Medicine and Medical Research
  • Fiber Optics and Integrated Optics

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