Preclinical testing was performed of an optical breast lesion localiza
tion fiber to guide surgical excision. The prototype device comprised
dual 0.010-inch (0.254-mm)-diameter hooks attached to the tip of a 1,0
00-mu m (0.03937-inch)-diameter optical fiber, which allowed retention
in soft tissue after passage through a 17-gauge extra-thin-wall needl
e. The proximal end of the optical fiber was attached to a 15-mW, 635-
nm diode laser, with a thumbscrew connector. The tip of the optical fi
ber was visible through several centimeters of breast tissue in two hu
man mastectomy specimens, which facilitated determination of the locat
ion of the hooks. The optical localization fiber may allow lesions to
be approached at surgery by many different paths. Clinical tests are i
ndicated to further evaluate this device.