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

Breast Fibroadenoma Clinical Trial

— EVALUATE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470051
• Other study ID #: BR007
• Status: Completed
• Start date: February 26, 2018
• Est. completion date: February 11, 2020

Study information

• Verified date: March 2021
• Source: QT Ultrasound LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Fibroadenoma
• 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.

Locations

Country	Name	City	State
United States	Memorial Care Long Beach	Long Beach	California
United States	Marin Breast Health Trial Center	Novato	California

Sponsors (1)

Lead Sponsor	Collaborator
QT Ultrasound LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast mass doubling time change	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.	90 days