Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies

Study Overview
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Brief Summary
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The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

Detailed Description
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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.

Official Title
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3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

Conditions
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Breast Cancers

Intervention / Treatment
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* Procedure: Ultrasound Scan
* Procedure: Mammography and Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Subjects<br>Ultrasound scan | Procedure: Ultrasound Scan<br>* 10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age.<br>|
| Active Comparator: Cancer<br>120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan | Procedure: Mammography and Ultrasound<br>* To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. | Self explanatory. | 2002-2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor. | Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy. | 2002-2014 |