Clinical Trials

Thoughtful and robust clinical trials result in exceptional clinical care, and that’s the mission of the Marin Breast Health Trial Center. Our team there is studying the efficacy of the QTscan® through ongoing clinical trials. The scans are delivered in an environment designed around the comfort and peace of mind of the women who participate. The QTscan has been cleared by the FDA for use in breast imaging as an adjunct to mammography. At this time, it is not intended as a replacement for screening mammography.

Our current clinical trial program includes the following studies:

Study Comparing QT Breast Imaging vs. Conventional Breast Imaging to Confirm Our Results From Protocol 2013001

Enrollment status: Trial completed and results expected 2018

Clinicaltrials.gov

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 and transmission ultrasound together compared to digital mammography and hand held ultrasound together in the evaluation of lesion(s) detected with diagnostic mammography.

Retrospective Study Comparing QT Breast Imaging vs. Conventional Breast Imaging - Results Published in Academic Radiology

Enrollment status: n/a

Results published in Academic Radiology.

Study Goal: The purpose of this retrospective study is to evaluate and compare the diagnostic accuracy of QT breast imaging vs. hand held ultrasound as an adjunct to digital mammography to aid in distinguishing a cyst versus a solid lesion in the breast using historical QT images.

Clinical Product Development Studying the QT Ultrasound® Breast Scanner With Volunteer Subjects

Enrollment Status: This study is enrolling participants by invitation only.

Clinicaltrials.gov

NIH Grant

Study Goal: To evaluate the detection and characterization of breast findings of QT Ultrasound and comparing to hand held ultrasound and/or digital mammography (with and without tomosynthesis) and to fulfill NIH Grant RO1CA138536 from the National Cancer Institute.

Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging

Enrollment status: Currently enrolling participants

Clinicaltrials.gov

Study Goal: A prospective multi-center case collection study of breast imaging examinations from women to evaluate the non-inferiority of QT Ultrasound compared to digital mammography-with tomosynthesis.

Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology

Enrollment Status: Currently enrolling participants

Clinicatrials.gov

Study Goal: A prospective multi-center case collection study of breast imaging examinations from women with non-suspicious breast masses to correlate the calculated mass doubling time using Quantitative Transmission Ultrasound (QT Ultrasound) with mass histology.

Clinical Trials are available at the following locations:

Sunnybrook Research Institute
University of Toronto
2075 Bayview Avenue
Toronto, Ontario,  Canada
Note: Trial is open to Canadian citizens only		 Oklahoma Center of Medical Imaging for Translational Cancer Research
The University of Oklahoma Stephenson Research and Technology Center
101 David L Boren Blvd
Norman, OK 73019
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