Trials / Completed
CompletedNCT03470051
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 27 (actual)
- Sponsor
- QT Ultrasound LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-02-26
- Primary completion
- 2020-02-11
- Completion
- 2020-02-11
- First posted
- 2018-03-19
- Last updated
- 2021-03-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03470051. Inclusion in this directory is not an endorsement.