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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03470051

Acronym

EVALUATE

Enrollment

Registered

2018-03-19

Start date

2018-02-26

Completion date

2020-02-11

Last updated

2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Fibroadenoma

Brief summary

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

Interventions

DIAGNOSTIC_TESTQT 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 design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Breast mass doubling time change	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026