Breast cancer remains the most frequently diagnosed cancer among women. It is projected that one in eight women will be diagnosed with breast cancer during her lifetime, and one in 42 women who turn 50 today will be diagnosed before the age of 60. Various screening and diagnostic technologies are employed to detect cancers early and enhance treatment outcomes. Mammography is currently the predominant imaging method, yet it has its limitations, especially in detecting cancers in dense breast tissue where 10-15% of cases yield inconclusive results and raise safety concerns. Now, a new clinical trial has found a highly accurate, 100% safe, and painless breast imaging technology to be as effective as digital breast tomosynthesis (DBT), also known as 3D mammography.

The Breast Acoustic CT system from QT Imaging Holdings (QTI, Novato, CA, USA) represents a breakthrough in non-invasive breast imaging. This FDA-cleared system utilizes both transmission and reflection ultrasound to provide detailed and complementary information about breast tissue, enabling a more effective assessment of breast health. This cutting-edge technology produces volumetric 3D images accurately and precisely, without the need for contrast agents or exposure to radiation. The company has now announced positive results from its second blinded multi-reader multi-case study, evaluating the diagnostic efficacy of the Breast Acoustic CT Scans for mass detection.

The comparative study involved 24 breast radiologists who reviewed 177 selected cases, including 66 with cancer, atypia, or a solid mass, and 111 normal or with non-solid benign abnormalities. The results demonstrated that QTI’s Breast Acoustic CT matches the effectiveness of DBT, with the area under the receiver operating characteristic curve (AUC) showing statistical non-inferiority to DBT, within a -0.05 AUC difference margin. This confirms that QTI’s technology is comparably effective in detecting breast lesions, with high specificity in identifying benign cysts, thus potentially reducing benign recall rates. Notably, breast cancer in women under 40, while less common, tends to be more aggressive and linked to poorer survival rates. Standard screening mammograms are generally not recommended for this age group due to the balance of risks and benefits. However, the findings from this study suggest that QTI’s technology could provide a much-needed potential alternative for younger women for whom traditional mammography is not advised.

“We are encouraged by the consistent high performance of QTI’s technology, especially in women with dense breasts,” said Dr. Bilal Malik, Chief Science Officer. “Along with the previously published results and from comparison of QTI’s scans with mammography, these trial results will be valuable for our planned FDA submission for a screening indication in younger women identified with above-average risk for developing breast cancer and who have not yet reached the age for conventional mammography-based screening.” 

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