A Pilot Study of the Sensitivity of the Quantitative Transmission (QT) Ultrasound Breast Scanner to Detect Breast Microcalcifications Identified with Digital X-Ray Mammography with or without Digital Breast Tomosynthesis

Study ID
STU 012017-085

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • Parkland Health & Hospital System
  • UT Southwestern-Other

Contact
Jagruti Patel
214/648-5983
Jagruti.Patel@UTSouthwestern.edu

Principal Investigator
Robert Lenkinski, Ph.D.

Summary

Patients in the uT Southwestern Breast Center undergoing digital x-ray mammography with or without digital breast tomosynthesis who are assessed as Bi-RaDS 4 or 5 due to suspicious microcalcification morphology and clustering will receive correlated imaging with the QT ultrasound Breast Scanner. Radiologist at QT ultrasound Labs and uT Southwestern will evaluate the visualization of microcalcifications on the ultrasound tomography studies relative to mammographic or tomosynthesis findings in the clinic.

Participant Eligibility

1.) Female subjects 30 and older.
2.) Breasts that will fit in the QT Ultrasound Breast Scanner
3.) Willing and able to comply with all study procedures.
4.) Complete clinically indicated digital mammography views (Craniocaudal/CC and Medio-Lateral Oblique/MLO) for one or both breast, with or without Digital Breast Tomosynthesis (with or without synthetic mammography views).
5.) Mammographically-detected microcalcifications.
6.) BI-RADS assessment category of 4 or 5.
7.) Ability to understand and the willingness to sign a written informed consent.