Our extensive preclinical and pilot clinical work has enabled us to model successful pivotal trials of the scanner. Our clinical results have validated our technology and multiple, ongoing and planned clinical trials are a strong part of our company culture.
Our published research in the International Journal of Biomedical Imaging shows that QT Ultrasound can identify all major anatomical features of the breast.
Our clinical trial program includes the following studies:
2013001 – Prospective study comparing QT breast imaging vs. conventional breast imaging to confirm our results from Protocol 2013003.
Enrollment status: Trial completed and results expected to be published in Fall 2017
Study Goal: A prospective multi-center case collection study of breast imaging examinations from women with mammographically-detected lesion(s) to evaluate the non-inferiority of digital mammography (XRM) and transmission ultrasound together compared to XRM and hand held ultrasound (HHUS) together in the evaluation of lesion(s) detected with diagnostic mammography.
2013003 – Retrospective study comparing QT breast imaging vs. conventional breast imaging. Results published in Academic Radiology.
Enrollment status: n/a
Study Goal: The purpose of this retrospective study is to evaluate and compare the diagnostic accuracy of QT breast imaging vs. HHUS as an adjunct to digital mammography (XRM) to aid in distinguishing a cyst versus a solid lesion in the breast using historical QT images.
BR004 - Clinical Product Development Studying the QT Ultrasound® Breast Scanner With Volunteer Subjects
Enrollment Status: This study is enrolling participants by invitation only.
Study Goal: To evaluate the detection and characterization of breast findings of QT Ultrasound and comparing to HHUS and/or mammography (digital mammography/DBT) and to fulfill NIH Grant RO1CA138536 from the National Cancer Institute.
BR005 - Study to investigate accuracy, call back and cancer detection rates,
Enrollment status: Currently enrolling participants
Study Goal: A prospective multi-center case collection study of breast imaging examinations from asymptomatic women to evaluate the non-inferiority of QT Ultrasound compared to digital mammography-digital breast tomography
BR007 - Study to evaluate false-positive biopsy rates using QT ultrasound breast imaging.
Enrollment status: Enrollment starts Summer 2017
Study Goal: A prospective multi-center case collection study of breast imaging examinations from women with benign-appearing solid breast masses to evaluate the non-inferiority of doubling time calculation using transmission ultrasound compared to standard of care in the evaluation of false-positive biopsy rates.