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

NCT03052166 | Completed

• 1 other identifier: BR005
• Study Type: observational
• Target: 755
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast

Outcome Measures

Primary Outcomes (1)

• Comparison of QT Ultrasound to DM-DBT

  Non-inferiority evaluation of sensitivity, specificity, positive predictive value and non-cancer recall rate.

  12 months

Study Arms (3)

Cohort A

The group of asymptomatic subjects who have been given BI-RADS 1 or 2 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan.

Device: QT Ultrasound scan

Cohort B

The group of asymptomatic women who have been given BI-RADS categories 4 or 4a, 4b, 4c or 5 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan.

Device: QT Ultrasound scan

Cohort C

The group of women who have been given BI-RADS categories 1, 2, 3, 4 or (4a, 4b, 4c), 5 or 6 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. Subjects are assigned to Cohort C when it has been determined they cannot be assigned to Cohort A or Cohort B.

Device: QT Ultrasound scan

Interventions

QT Ultrasound scan DEVICE

QT Ultrasound scan

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women, age 18 and older

You may qualify if:

• Female
• Age 18 or older
• Willing to receive a QT Ultrasound Breast Scan
• Willing and able to provide written Informed Consent prior to any research-related procedure(s)
• Eligible for routine screening mammography as per ACR guidelines
• 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
• \. Willing and able to submit available breast imaging - for one or both breasts, before or after, their QT scan.

You may not qualify if:

• Pregnancy
• Currently breastfeeding
• Allergies to device materials
• 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
• Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast
• Breasts too large for scanner, i.e. inability to successfully "fit" breast after the subject is placed on scanner
• Body weight greater than 400 lbs. (180 kg)
• Has a concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject, from participating in the study
• 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.
• History of breast cancer in the past 12 months.
• Most recent screening mammography exam was completed more than 3 months but less than 11 months prior.
• History of breast surgeries or interventional breast procedures in the past 12 months, except for Fine Needle Aspiration(s) or Cyst Aspiration(s)

Sponsors & Collaborators

• QT Ultrasound LLC: lead

Study Sites (2)

Memorial Care Long Beach

Long Beach, California, 90806, United States

Location

Marin Breast Health Trial Center

Novato, California, 94949, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: April 18, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)