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

Age Range:18 - Any
Start Date:April 18, 2017
End Date:November 9, 2019
Contact:Daniel Miconi, MBA

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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-Digital Breast Tomography (DM-DBT)

Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed
ultrasound plane waves through the breast, as well as collects reflected ultrasound output.
As the patient lays prone on a table, the breast is submerged in a warm water bath. The
transmitter and receiver assembly moves around the suspended breast to record data for
successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear
transducer's array encircle the breast to gather data from the tissue structures of the
breast, from nipple to chest wall. Information gathered from this automated QT scan
encompasses the entire breast which is currently not commercially available using any other
ultrasound technology.

This is a prospective, multicenter, multi-arm case collection study, with IRB approval. The
study will follow an adaptive design with an initially planned total enrollment of
approximately 600 cases to include both benign and malignant cases, representative of all
tissue densities.

The images and clinical data accrued in this prospective case collection will be used for
creation of a database to facilitate future reader's studies, publications, building teaching
files, and future marketing for QT Ultrasound.


1. Female

2. Age 18 or older

3. Willing to receive a QT Ultrasound Breast Scan

4. Willing and able to provide written Informed Consent prior to any research-related

Cohort A and B Subjects that do not meet these Inclusion Criteria will be evaluated for
Inclusion in Cohort C

1. Eligible for routine screening mammography as per ACR guidelines

2. Willing and able to submit or complete at the clinical site a Digital Mammography with
Digital Breast Tomosynthesis exam (to include Craniocaudal (CC) and Mediolateral
Oblique (MLO) views - for one or both breasts, within 3 months, before or after, their
QT scan.

Cohort C

1. Willing and able to submit available breast imaging - for one or both breasts, before or
after, their QT scan.


1. Pregnancy

2. Currently breastfeeding

3. Allergies to device materials

4. Physical inability to tolerate the procedure on the scanner, i.e. inability to lie
prone and still for up to 30 minutes at a time

5. Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the
scanned breast

6. Breasts too large for scanner, i.e. inability to successfully "fit" breast after the
subject is placed on scanner

7. Body weight greater than 400 lbs. (180 kg)

8. Has a concurrent disease or condition which in the judgment of the Principal
Investigator disqualifies the subject, from participating in the study

9. Magnetic material in the chest which in the judgement of the Principal Investigator
would interfere with or be impacted by the magnets within the study device.

Cohort A and B Subjects that meet any of these conditions below will not be eligible for
Cohort A or B and will be evaluated for eligibility in Cohort C.

1. History of breast cancer in the past 12 months.

2. Most recent screening mammography exam was completed more than 3 months but less than
11 months prior.

3. History of breast surgeries or interventional breast procedures in the past 12 months,
except for Fine Needle Aspiration(s) or Cyst Aspiration(s)
We found this trial at
Long Beach, California 90806
Phone: 562-933-7804
Long Beach, CA
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3 Hamilton Landing
Novato, California 94949
Principal Investigator: Lauralyn Markle, MD
Phone: 415-842-7400
Novato, CA
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