FMTVDM*-BEST©℗ (B.E.S.T.©℗) Breast Cancer Imaging Test (BBCIT©℗): An Enhanced Quantitative Method for Performing Molecular Breast Imaging (MBI)

Abstract

Background: Molecular breast imaging (MBI) uses nuclear isotopes to “qualitatively” look at the delivery and uptake by breast tissue. Clinicians then make interpretations based upon these images. Such qualitative image interpretation has limited the applicability of MBI. MBI “quantitative” imaging using enhancement of regional blood flow differences (RBFDs) augmenting isotope delivery and uptake differentiating these RBFDs and metabolic differences [Breast Enhanced Scintigraphy Test (B.E.S.T.) Imaging] has been shown to enhance diagnostic measurement of cancer and pre-cancerous tissue. Methods: In an effort to develop a “quantitative” method to differentiate breast calcium, normal breast tissue, and inflammatory changes of the breast, pre-cancers and breast cancer, this study set out to answer three fundamental questions. First, what are the fundamental differences between these four tissue types? Second, is there a method, which can briefly “enhance” these differences? Finally, can these differences be accurately “quantified?” Following the development of this method [FMTVDM-BEST©℗ (B.E.S.T.©℗) Breast Cancer Imaging Test] B.E.S.T.©℗ Breast Cancer Imaging Test (BBCIT©℗) was used to image 195 people and to compare these results with mammography and tissue pathology. Results: In the first part, of this study, 10 women were compared using both MIRALUMA (currently employed MBI) and BBCIT©℗. No statistical difference was seen between MIRALUMA and BBCIT©℗ and women with “normal” breast tissue. Women with inflammatory breast changes showed a statistically significant (P < .05) increase in isotope measuring RBFDs and metabolism using BBCIT©℗. This difference was even more significant (P < .005) in women with breast cancer where there are even greater RBFDs and metabolism. In part two of the study 195 people were studied using BBCIT©℗. The results were compared with biopsy specimens. BBCIT©℗ demonstrated an exponential increase in tracer uptake as tissue transitioned from calcium deposits to normal breast tissue to inflammatory changes of the breast to precancerous tissue changes with the greatest measured activity occurring in breast cancer proper. When maximal count activity (MCA) was compared between these tissue types, there was a statistically significant (P <0.001) difference between normal breast tissue and inflammatory changes of the breast (ICB), between ICB and pre-cancerous atypia (A), and between A and cancer (CA). Conclusion: Enhanced delivery and uptake of isotope was statistically significantly increased using BBCIT©℗ compared with the currently employed MIRALUMA Molecular Breast Imaging (MBI) approach, which is a non-enhanced qualitative method. This statistically enhanced delivery and uptake of isotope, once “quantified,” (BBCIT©℗) allows for the “quantitative” differentiation of breast tissue, including earlier detection of changes in breast cancer and the ability to “quantitatively” measure if treatment of breast cancer, pre-cancers and inflammatory breast changes is or isn’t working.