Accession Number : ADA303790

Title :   Fluorescence Optic Fiber Stereotactic Needle Ratiometer for Breast Tumor Diagnosis.

Descriptive Note : Annual rept. 23 Sep 94-22 Sep 95,

Corporate Author : MEDISCIENCE TECHNOLOGY CORP CHERRY HILL NJ

Personal Author(s) : Tang, Guichen C.

PDF Url : ADA303790

Report Date : OCT 1995

Pagination or Media Count : 19

Abstract : Activities during the first year focused on engineering the optic fiber probe and needle, on the breadboard design of the fluorescence instrument and on establishing the clinical protocol and patient consent form that must be followed in the clinical feasibility study part of the project. Fabrication of the device and trials on patients could not be undertaken in the absence of approval by the cooperating clinic's (Mass. Gen. Hospital) Institutional Review Board ('IRB') The constraints on the progress of the approval centered around the careful and protracted review by the IRB which has just recently granted approval based on its acquiescence that the device is of nonsignificant risk ('NSR') for the intended application. Still awaited from the lRB are revisions in their Patient Consent Form to be resubmitted to the Human Use Review and Regulatory Affairs Division, HO, USARMRMC.

Descriptors :   *FIBERS, *FLUORESCENCE, *DIAGNOSIS(MEDICINE), *MAMMARY GLANDS, *BREAST CANCER, OPTICS, PROBES, RISK, HUMANS, CLINICAL MEDICINE, NEOPLASMS, ENGINEERING, FEASIBILITY STUDIES, BREADBOARD MODELS, USER NEEDS, INSTRUMENTATION.

Subject Categories : Medicine and Medical Research
      Anatomy and Physiology
      Fiber Optics and Integrated Optics

Distribution Statement : APPROVED FOR PUBLIC RELEASE