Classification of Breast Masses Using SAVE Method

Overview

About this study

The purpose of this research is to evaluate the efficacy of a new breast tissue assessment tool that provides new diagnostic information about breast masses and potential for early classification of malignant masses.

This study is being done to:

• Test an investigational breast imaging system;

• Image the breast and see if we can differentiate lesions by using the investigational imaging system;

• Test an investigational breast stiffness measurement method

• Test and compare to an FDA approved ultrasound stiffness imaging system (GE LOGIQ E9 (LE9)

• Compare to ultrasound images using Alpinion clinical ultrasound platform, FDA approved ECUBE 12 and a non-FDA approved ECUBE 12R

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation. It is anticipated that the majority of these participants will undergo a biopsy (standard of care). The SAVE data collection from each participant will take place before biopsy or at least 2 weeks post biopsy.

 

Exclusion Criteria: 

No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices. Since we are using B-mode images to guide the SAVE data acquisition, we only include patients with masses detectable under ultrasound.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Azra Alizad, M.D.

Open for enrollment

Contact information:

Cynthia Andrist

(507)293-3290

Andrist.Cynthia@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions