SBIR-STTR Award

It is the object of this Phase I study to design, assemble, and bench test a commercial prototype fluorescence imaging system for use in endoscopic localization of in situ cancer. This prototype instrument is to be based on extensive previous studies by the principal investigator in endoscopic fluorescence imaging, and is directed at developing a commercially viable system. Previous research units do not lend themselves to direct commercialization due to cost, complexity, and difficulty of use. This instrument is based on the fluorescence and tumor localization properties of hematoporphyrin derivative (HpD) or its more purified form di-hematoporphyrin-ether (DHE). DHE is presently undergoing clinical trials.Phase I will emphasize characterization of important parameters and components along with phantom and bench testing. Phase II will encompass a commercial system development for clinical testing. If a reliable cost effective system can be developed, it will have a significant potential market for localizing early stage cancer in the lung, bladder, stomach, cervix, and skin.National Cancer Institute (NCI)

Fluorescence markers for the localization and diagnosis of cancer are finding increased use and interest. In particular, the use of hematoporphyrin derivative (HpD) or its more purified form dihematoporphyrin-ether (DHE) are undergoing extensive studies as localizing agents. Early detection and localization of in-situ cancers can lead to a significant increase in five year survival rates. The objective of this Phase-II proposal is to develop and test a prototype commercial fluorescence endoscope system to accurately and reliably localize early, carcinoma in-situ endobronchial cancer. The system will be totally video based and will provide both color and fluorescence images. The excitation source is to be laser based, with either a krypton laser or a frequency doubled GeAlAs diode laser. Both video systems will be CCD devices. The total endoscopic image will be transferred to the video camera remotely from the endoscope ocular and all viewing will be via a high resolution video monitor. The system will include a fluorescence detection probe with audio signal, which will include distance and angle correction, along with tissue autofluorescence background correction. Clinical testing will be done at the USC School of Medicine. Emphasis will be on the development of a commercially viable fluorescence endoscopic system that can be used with a variety of standard endoscopes. Special attention will be paid to making the system inexpensive, easy to use and extremely sensitive and selective.

Thesaurus Terms:
biomedical engineering, instrumentation clinically oriented, diagnostic tests, early diagnosis, neoplasms diagnosis, neoplasms of respiratory system, lung neoplasms, optics, imaging-visualization, endoscopy, radiography, fluoroscopy biomarkers, diagnostic quality-standards, dyes, fluorescent dyes and probes, information dissemination, television, optics, fiber optics, optics, image processing analysis and display, optics, lasers, porphyrins animals, chordates, mammals, rodents, myomorpha, mice (laboratory), human, clinical, cytology, histopathology