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

• ClinicalTrials.gov Identifier: NCT03470051
• Recruitment Status: Completed
• First Posted: March 19, 2018
• Last Update Posted: March 18, 2021
• Sponsor: QT Ultrasound LLC
• 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: March 18, 2021
• Actual Study Start Date: February 26, 2018
• Actual Primary Completion Date: February 11, 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.

• 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:

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 17, 2021): 27
• Original Estimated Enrollment (submitted: March 16, 2018): 150
• Actual Study Completion Date: February 11, 2020
• Actual Primary Completion Date: February 11, 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 information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

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
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: QT Ultrasound LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: QT Ultrasound LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: QT Ultrasound LLC
• Verification Date: March 2021