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Trial record 2 of 2 for:    Br005

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

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ClinicalTrials.gov Identifier: NCT03052166
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
QT Ultrasound LLC

Tracking Information
First Submitted Date February 7, 2017
First Posted Date February 14, 2017
Last Update Posted Date February 25, 2019
Actual Study Start Date April 18, 2017
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2018)
Comparison of QT Ultrasound to DM-DBT [ Time Frame: 12 months ]
Non-inferiority evaluation of sensitivity, specificity, positive predictive value and non-cancer recall rate.
Original Primary Outcome Measures
 (submitted: February 9, 2017)
To determine if readers' mean proportion of non-cancer recall rate using QT Ultrasound is non-inferior to the readers mean proportion of non-cancer recall rate using DM-DBT [ Time Frame: 18 months ]
Non-inferiority margin of 0.05
Change History Complete list of historical versions of study NCT03052166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging
Official Title 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 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Women, age 18 and older
Condition Breast
Intervention Device: QT Ultrasound scan
QT Ultrasound scan
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Device: QT Ultrasound scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 22, 2019)
2500
Original Estimated Enrollment
 (submitted: February 9, 2017)
350
Estimated Study Completion Date November 9, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

INCLUSION CRITERIA All Subjects

  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 procedure(s)

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.

EXCLUSION CRITERIA All Subjects

  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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Daniel Miconi, MBA 415-842-7425 daniel.miconi@qtultrasound.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03052166
Other Study ID Numbers BR005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party QT Ultrasound LLC
Study Sponsor QT Ultrasound LLC
Collaborators Not Provided
Investigators
Study Director: Rajni Natesan, MD Chief Medical Officer
PRS Account QT Ultrasound LLC
Verification Date February 2019