Michael Barbella, Managing Editor05.28.24
QT Imaging Holdings Inc.'s breast scanning technology is equivalent to 3D mammography in detecting lesions, clinical trial results indicate.
Published in Academic Radiology, the multi-case study data compared the diagnostic performance of QTI’s Breast Acoustic CT Scans with digital breast tomosynthesis (DBT) in detecting masses. Twenty-four breast radiologists participated in a study of 177 selected cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality). The study found that QTI’s Breast Acoustic CTTM is similarly effective as DBT, also known as 3D mammography; specifically the area under receiver operating characteristic curve (AUC) was statistically non-inferior for the QTI scan compared with DBT for the AUC difference margin of -0.05. Translation: QTI technology is as effective as DBT in detecting breast lesions as a whole, with high specificity in determining benign cysts and thus decreasing benign recall rates. Statistical analysis was performed by Dr. Yulei Jiang from the Department of Radiology of the University of Chicago.
“We are encouraged by the consistent high performance of QTI’s technology, especially in women with dense breasts. 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,” QT Imaging Chief Science Officer Dr. Bilal Malik said.
While fewer than 5% of women with breast cancer are diagnosed before the age of 40,1 those cancers are usually aggressive, and young patients suffer from poor survival outcomes. Routine screening mammograms are not recommended for women under 40 because risks outweigh potential benefits at this young age. However, published results suggest that QTI’s technology can be a potential alternative to mammography for women too young to undergo mammography screening.
“Accurate and safe breast cancer screening is crucial for the 40% of women in U.S. with dense breasts. Standardization and broad accessibility of any technology are essential to minimize the financial and emotional impacts of unnecessary biopsies and call backs," stated Jennifer Simmons, M.D., breast surgeon and integrative oncologist at Real Health M.D. "This study suggests that these requirements are now being met. Cancers are occurring in much younger women today than when I started to practice. We need a safe imaging solution for young women. I am hopeful that QTI’s technology is that solution.”
QT Imaging Holdings Inc. is a public medical device company engaged in research, development, and commercialization of body imaging systems using low frequency sound waves. Its strategy is predicated upon the fact that medical imaging is critical to disease detection, diagnosis, and treatment.
Reference
1 American Cancer Society. Breast Cancer Facts and Figures 2022-2024. Atlanta, Ga.:American Cancer Society, 2022.
Published in Academic Radiology, the multi-case study data compared the diagnostic performance of QTI’s Breast Acoustic CT Scans with digital breast tomosynthesis (DBT) in detecting masses. Twenty-four breast radiologists participated in a study of 177 selected cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality). The study found that QTI’s Breast Acoustic CTTM is similarly effective as DBT, also known as 3D mammography; specifically the area under receiver operating characteristic curve (AUC) was statistically non-inferior for the QTI scan compared with DBT for the AUC difference margin of -0.05. Translation: QTI technology is as effective as DBT in detecting breast lesions as a whole, with high specificity in determining benign cysts and thus decreasing benign recall rates. Statistical analysis was performed by Dr. Yulei Jiang from the Department of Radiology of the University of Chicago.
“We are encouraged by the consistent high performance of QTI’s technology, especially in women with dense breasts. 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,” QT Imaging Chief Science Officer Dr. Bilal Malik said.
While fewer than 5% of women with breast cancer are diagnosed before the age of 40,1 those cancers are usually aggressive, and young patients suffer from poor survival outcomes. Routine screening mammograms are not recommended for women under 40 because risks outweigh potential benefits at this young age. However, published results suggest that QTI’s technology can be a potential alternative to mammography for women too young to undergo mammography screening.
“Accurate and safe breast cancer screening is crucial for the 40% of women in U.S. with dense breasts. Standardization and broad accessibility of any technology are essential to minimize the financial and emotional impacts of unnecessary biopsies and call backs," stated Jennifer Simmons, M.D., breast surgeon and integrative oncologist at Real Health M.D. "This study suggests that these requirements are now being met. Cancers are occurring in much younger women today than when I started to practice. We need a safe imaging solution for young women. I am hopeful that QTI’s technology is that solution.”
QT Imaging Holdings Inc. is a public medical device company engaged in research, development, and commercialization of body imaging systems using low frequency sound waves. Its strategy is predicated upon the fact that medical imaging is critical to disease detection, diagnosis, and treatment.
Reference
1 American Cancer Society. Breast Cancer Facts and Figures 2022-2024. Atlanta, Ga.:American Cancer Society, 2022.