Viscoelastic Parameters Estimation And Imaging For The Assessment Of Axillary Lymph Nodes
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: 13-006035
Sponsor Protocol Number: 13-006035
About this study
This study is being done to:
• Test an investigational stiffness measurement and imaging method on the lymph node found in the underarm area.
• Compare investigational imaging to sonography images.
• Compare investigational information to FDA approved US elasticity imaging conducted by SuperSonic Imaging (SSI) machine on the same lymph node in your underarm area.
• Compare to FDA approved ultrasound stiffness imaging system (GE Logiq E9)
• Compare to ultrasound images using Alpinion clinical ultrasound platform, FDA approved ECUBE 12and a non-FAD 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:
- Female patients who have axillary lymph nodes which may be benign or may have been diagnosed or suspicious for breast cancer will be candidates for enrollment.
- It is anticipated that the majority of these participants will undergo an US guided lymph node biopsy (standard of care). U.S. and CUSE/SDUV data collection from each participant will take place before or 2 weeks after lymph node biopsy/aspiration.
Exclusion Criteria:
- Having any condition that does not allow proper use of our imaging devices.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Azra Alizad, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available