GammaL c device provides accurate lesion localization and facilitates needle-guided biopsy

Dec 2 2009

Breast-Specific Gamma Imaging (BSGI) is a molecular breast imaging technique increasingly being used in the diagnostic workup of patients with indeterminate mammograms and has demonstrated the ability to detect cancers missed by mammography and ultrasound. However, broad acceptance of this imaging technique has been limited due to the inability to perform minimally invasive, image-guided biopsy procedures under this modality. This limitation has now been addressed by the development of a stereotactic BSGI needle guidance system according to findings presented today by Cynthia Lorino, MD of the Montgomery Breast Center of Montgomery, AL at the annual meeting of the Radiological Society of North America (RSNA). In this study, the GammaL c® device, an accessory to the Dilon 6800 Gamma Camera provided accurate lesion localization and facilitated needle-guided biopsy. The GammaL c® accessory is pending FDA clearance.

This stereotactic lesion localization system was developed to allow BSGI-guided, vacuum-assisted needle biopsy and the purpose of the study was to examine the clinical viability of the system. Patients who were routinely scheduled for a needle biopsy based on clinical findings and also had a focal abnormality on BSGI were invited to participate in the clinical trial of the GammaL c® system.

For the study, 17 patients of variable breast sizes patients with lesions ranging from 4mm to 70mm underwent BSGI guided vacuum-assisted needle biopsies. All of the biopsy results were concordant with known Sestamibi avid pathologies successfully demonstrating the clinical accuracy of this guidance system. In addition, in some cases, both the BSGI diagnostic examination and Gamma-Guided biopsy were conducted in a single day using only one administration of Sestamibi. The Authors concluded by saying, "The GammaLoc stereotactic biopsy apparatus provides an accurate, convenient means for conducting vacuum-assisted needle biopsy of breast abnormalities."

"Whenever an imaging study shows a suspicious finding there must be some means for further evaluation. In our experience, the BSGI demonstrates findings that are frequently malignant and which are not evident on mammography or ultrasound. This is why it is key that we have a way to sample this tissue. This device allows for that in an easy and efficient manner," said Dr. Cynthia Lorino, Director of Mammography Services, at the Montgomery Breast Center of Montgomery, AL.

SOURCE Dilon Diagnostics