3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
25 Years
N/A
Female
Breast Cancers
Trial Information
3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Outcome Description:
Self explanatory.
Outcome Time Frame:
2002-2014
Safety Issue:
No
Principal Investigator
Paul L. Carson, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan
Authority:
United States: Institutional Review Board
Study ID:
2001-0124
NCT ID:
NCT00721903
Start Date:
March 2000
Completion Date:
May 2013
Related Keywords:
- Breast Cancers
- Breast Neoplasms
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