Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
Not Applicable
Completed
- Conditions
- Breast Cancers
- Registration Number
- NCT00721903
- Lead Sponsor
- University of Michigan
- Brief Summary
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
- Detailed Description
To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 88
Inclusion Criteria
- Newly diagnosed breast cancer prior to receiving breast cancer therapy.
- Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.
Exclusion Criteria
- Poorly controlled diabetes.
- Contralateral mastectomy prior to neoadjuvant chemotherapy.
- Not a surgical candidate.
- No previous axillary lymph node dissection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. 2002-2014 Self explanatory.
- Secondary Outcome Measures
Name Time Method Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor. 2002-2014 Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.
Trial Locations
- Locations (1)
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Hospital🇺🇸Ann Arbor, Michigan, United States