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Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology (EVALUATE)

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ClinicalTrials.gov Identifier: NCT03470051
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
QT Ultrasound LLC

Tracking Information
First Submitted Date March 12, 2018
First Posted Date March 19, 2018
Last Update Posted Date February 25, 2019
Actual Study Start Date February 26, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 2, 2018)
Breast mass doubling time change [ Time Frame: 90 days ]
The change in calculated mass doubling time using Quantitative Transmission Ultrasound (QT Ultrasound) from a minimum of two study timepoints will be measured and compared to mass histology.
Original Primary Outcome Measures
 (submitted: March 16, 2018)
Breast mass doubling time change [ Time Frame: 90 days ]
The change in calculated mass doubling time using Quantitative Transmission Ultrasound (QT Ultrasound) from baseline will be measured and compared to mass histology.
Change History Complete list of historical versions of study NCT03470051 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 in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology
Official Title 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.
Brief Summary This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Needle breast biopsy
Sampling Method Non-Probability Sample
Study Population Subjects with a non-suspicious breast mass will be recruited.
Condition Breast Fibroadenoma
Intervention Diagnostic Test: QT Ultrasound
All subjects will be asked to agree to an ultrasound-guided breast needle biopsy by a qualified radiologist experienced in this procedure if not already completed prior to study entry.
Study Groups/Cohorts
  • (2) QT Ultrasound scans prior to breast biopsy
    Subjects will undergo a baseline QT scan, and a follow-up QT scan performed between 90 days and 180 days from their baseline QT Scan accompanied by a HHUS and ultrasound-guided breast biopsy following the first follow-up QT scan. BI-RADS will be confirmed by the radiologist at the time of the first HHUS. Subjects will receive a telephone follow-up contact approximately 2-3 business days after their ultrasound-guided breast biopsy to assess if any adverse events have occurred. Subjects will be asked to come back for an additional follow-up QT Scan 12 months from the time of their baseline QT Scan.
    Intervention: Diagnostic Test: QT Ultrasound
  • (0-1) QT Ultrasound scans prior to breast biopsy

    Subjects that have not had (2) two QT Scans before their breast biopsy and who haven't yet had a breast biopsy will undergo an optional baseline QT scan accompanied by a HHUS and ultrasound-guided breast biopsy. BI-RADS will be confirmed by the radiologist. Subjects will receive a telephone follow-up contact approximately 2-3 business days after their ultrasound-guided breast biopsy to assess if any adverse events have occurred. Subjects will be asked to come back for a follow-up QT Scan between 90 and 180 days from the time of their study biopsy.

    Subjects that have had a breast biopsy on their identified breast mass(es) prior to study enrollment and have not already had two (2) QT Scans will undergo an optional baseline QT scan if between 0 and 30 days from their breast biopsy.

    Subjects will be asked to come back for a follow-up QT Scan 12 months from the time of their study biopsy.

    Intervention: Diagnostic Test: QT Ultrasound
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: March 16, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2021
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Female
  2. Age 18 or older
  3. Willing to receive QT Ultrasound Breast Scans
  4. Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study
  5. Willing and able to provide Informed Consent prior to any research-related procedure(s)
  6. Have an identified solid non-suspicious breast mass

Exclusion Criteria:

  1. Pregnancy
  2. Currently breastfeeding
  3. Magnetic material in the chest which in the judgement of the Principal Investigator would interfere or be impacted by the magnets utilized with the study device.
  4. Not willing to provide information for primary care physician
  5. History of breast cancer
  6. History of treated or untreated cancer of a non-breast origin which in the judgment of the Principal Investigator would be a concern for metastatic disease to the breast
  7. Physical inability to tolerate the QT scan, i.e. inability to lie prone and still for up to 30 minutes at a time
  8. Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast(s)
  9. Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
  10. Body weight greater than 400 lbs. (180 kg)
  11. Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Subjects must be female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marin Breast Health Trial Center (415) 842-7400 info@marinbreasthealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03470051
Other Study ID Numbers BR007
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a 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