JULY 17, 2009--Imaging Diagnostic Systems, Inc. (IDSI; Fort Laurderdale, FL; OTCBB:IMDS) developer of laser breast imaging systems, says it has begun a breast cancer imaging study at the Charité medical university in Berlin, Germany. The study will examine the potential role of its model 1020 computed tomography laser mammography (CTLM) system as an enhanced breast cancer screening tool when used in combination with the fluorescent dye Indocyanine Green (ICG). The study will be conducted at the Campus Virchow-Klinikum; the principal investigator is radiologist Dr. Alexander Poellinger.
The CTLM breast imaging system uses patented continuous wave (CW) laser technology and computer algorithms to create 3-D imagery. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CTLM is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
"In other studies, optical imaging using fluorescent dyes have shown great promise to detect and differentiate malignancies. By using a fluorescent dye in a clinical breast cancer study, we hope to demonstrate an enhancement of the sensitivity and the specificity of diffuse optical tomography. For this purpose we will use a modified CTLM breast scanner that is capable of acquiring both absorption and fluorescence images," said Poellinger.
The ICG fluorescent dye has a distribution pattern in the human body similar to that of extracellular MRI and CT contrast agents and it is already approved for other medical applications. The IDSI model 1020 CTLM scanner that will be used in the study has been specially modified to be able to both excite the ICG dye and image its fluorescence in breast tissue. Following injection of ICG into the patient, the scanner produces 3D images of the localized concentration of the dye. These images are expected to show increased extravasation and accumulation of the dye in malignant tissue.
IDSI users have performed over 15,000 CTLM clinical cases worldwide. The company is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the CTLM system to be used as an adjunct to mammography. The FDA has determined that the company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States; it has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
For more information, visit our IDSI's website.
Posted by Barbara G. Goode, [email protected], for BioOptics World.