A Study to Compare Conventional Heart Echo Measurements with Newer 2 and 3 Dimensional Measurements of Mechanical Heart Strain after Trastuzumab Infusion
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 15-008290
Sponsor Protocol Number: 15-008290
About this study
The purpose of this study is to compare conventional assessment of systolic ventricular function on a 2D heart echo with an assessment of more immediate changes in heart mechanics using 2D and 3D measurements of deformation and strain in patients undergoing infusion of Trastuzumab for breast cancer.
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
- Histological diagnosis of breast cancer and undergoing trastuzumab treatment
- Her2 gene amplification (2+, 3+) by immunohistochemical analysis (IHC) or fluorescence in situ hybridization (FISH)
- Stage I-II-III-IV
Exclusion Criteria
- Inadequate image quality
- Irregular R-R Interval
- Age <18 years
- Previous cardiovascular disease (coronary artery disease, congestive heart failure, cardiomyopathy)
- Moderate or severe valvular stenosis or regurgitation
- Uncontrolled hypertension
- Moderate to severe pericardial effusion or pericardial metastasis
- CNS metastasis
- Previous trastuzumab treatment
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 Hector Villarraga, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available