Clinic Study Confirms MBI High Absolute Sensitivity for Supplemental

Clinic Study Confirms MBI High Absolute Sensitivity for Supplemental

According to this website, /, A breakthrough study conducted by Mayo Clinic and published in the AJR has clinically confirmed that Molecular Breast Imaging (MBI) yields superior imaging and low radiation exposure for women with dense breast tissue, which can affect up to 40% of the female population. In the study, the LumaGEM® MBI System establishes its clinical importance by significantly demonstrating a reduction in radiation dose from 20 mCi[iii]to 8 mCi, a dose reduction not achievable with older-generation scintillating gamma cameras, known as scintimammography or breast-specific gamma imaging (BSGI) systems[iv].

The AJR study, titled, Molecular Breast Imaging at Reduced Radiation Dose for Supplemental Screening in Mammographically Dense Breasts, determined that adding MBI to mammography enabled detection of an additional 8.8 cancers per 1000 women screened. Of all the cancers detected by MBI, 79% (11/14) were invasive, of which 82% were node negative; the type of cancer that is addressable with early intervention.

Prior studies have cited MBI for signi?cantly increasing detection of breast cancer in dense breasts, but have noted the need for low-dose imaging technology to broaden the use of MBI in supplemental screening. This is specifically for the segment of women with dense breasts who are above normal risk and below high risk for breast cancer, and do not meet risk criteria for MRI screening.[v]

In this study, 1585 women with dense breast tissue underwent screening mammography and adjunct MBI. Cancer detection rate, sensitivity, specificity, and positive predictive value (PPV3) of biopsies performed were measured. Sensitivity of mammography was 23.8%, sensitivity of MBI was 81% and the sensitivity of mammography with adjunct MBI was 90.5%. The AJR study compares the absolute increase of MBI sensitivity (67%) to similarly designed studies for ultrasound (39%), tomosynthesis (34%) and MRI (56%). There was only a slight increase in biopsy rate. Although the specificity, PPV3 and NPV for MBI was comparable to previous clinical publications, this study recognizes the efficacy of MBI at almost one-third of the radiation exposure.

The AJR study supports the utilization of such systems as LumaGEM® MBI as an alternative to Ultrasound and MRI as a supplemental screening tool for the women with dense breast tissue. The diagnostic value of MRI is often offset by its increased burden to the healthcare system as measured by its diagnostic complexity, contraindications and high cost of equipment and per procedure[vi], [vii], [viii]. The supplemental screening value of ultrasound is diminished because it detects as few as 50% of cancers in women with dense breast tissue[ix], at substantially increased cost[x].

The history of molecular breast imaging is a long and convoluted one. Several agents have been shown to be taken up by cancer; however, sufficient reliability has not been proven. Technetium-based compounds offer a real opportunity, but require adequate, specific and novel instrumentation above and beyond standard general detectors to provide reliable images at an acceptable dose. Until now, this has been an elusive goal, said R. James Brenner, M.D., J.D., FACR, FCLM. The current Mayo study provides a basis to think about the feasibility of now incorporating molecular imaging in the regular clinical evaluation of women, especially for patients at high risk or with dense breasts.

Gamma Medica, the manufacturer of LumaGEM MBI, has optimized its dual-head Digital Direct Conversion Gamma Imaging (DDCGI) to reduce administered radiation dose. The DDCGI dual-head configuration of the MBI system increases detection of sub-centimeter tumors relative to single-head systems[xi].

This study addresses the biggest criticism from detractors and supports that the LumaGEM MBI system significantly increases cancer detection rates for women with dense breast tissue, said Jim Calandra, CEO, Gamma Medica. MBI is now a proven tool in the fight against breast cancer and I commend the authors of this Mayo Clinic study. This publication emphasizes the value of MBI with reasonable low doses and laudable outcomes that arent achievable by other molecular imaging modalities.

About Gamma Medica

Gamma Medica, Inc., is dedicated to the development of advanced digital imaging technologies that address the growing importance of overcoming the critical shortcomings of mammography and other screening modalities in the early detection of breast cancer. The company designs, builds and services the LumaGEM® MBI system, the first commercially available, FDA-cleared planar, dual head, fully solid-state digital imaging system utilizing dual-head Digital Direct Conversion Gamma Imaging (DDCGI) technology for molecular breast imaging. For more information visit www.gammamedica.com

[i]Rhodes, et. al Radiology: Volume 258: Number 1January 2011

[ii]  Hruska, C et. al AJR:191, December 2008

[iii] Op cit. 1

[iv] Dickerscheid D, et. al. Contrast-noise-ratio (CNR) analysis and optimisation of breast-specific gamma imaging (BSGI) acquisition protocols. EJNMMI research. 2013;3(1):21. 22

[v] Op cit. 1

[vi]  Elmore   JG ,  Armstrong   K ,  Lehman   CD ,  Fletcher   SW .  Screening for breast cancer .  JAMA   2005 ; 293 ( 10 ): 1245 1256 .

[vii] Berg   WA ,  Blume   JD ,  Adams   AM ,  et al .  Reasons women at elevated risk of breast cancer refuse breast MR imaging screening: ACRIN 6666 .  Radiology   2010 ; 254 ( 1 ): 79 87 .

[viii]

[ix] Berg WA, et al. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008;299(18):2151-63.

[x] Sprague, BL, Bene?ts, Harms, and Cost-Effectiveness of Supplemental Ultrasonography  Screening for Women With Dense Breasts, Ann.Intern.Med. published online on 9 December 2014.

[xi] Op cit. 2

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