Classification of Breast Masses Using SAVE Method
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-009399
NCT ID: NCT04841252
Sponsor Protocol Number: 12-009399
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:
Patricia O'Neil
(507) 284-1375
ONeil.Patricia@mayo.edu
|
More information
Publications
Publications are currently not available