Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of a breast ultrasound method for the diagnosis of breast cancer. Diagnostic procedures, such as breast ultrasound, may help find and diagnose breast cancer, and may help measure a patient's response to earlier treatment. The purpose of this research is to test the effectiveness of a new investigational breast ultrasound method to detect an abnormality in the breast, and assess response to breast cancer treatment.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Determine the diagnostic performance of the proposed method in a population of pre-biopsy patients with suspicious breast masses and correlate the proposed method results with pathology as the gold standard. II. Assess and predict the response to preoperative chemotherapy in breast cancer patients using the proposed method and compare the results to magnetic resonance imaging (MRI) as control and surgical pathology for pathological complete response (PcR). III. Determine the diagnostic performance of the proposed method in identifying metastatic axillary lymph node in patients with suspected or known breast cancer lesions; correlate the results with pathology as the gold standard. OUTLINE: AIM 1: Participants undergo a breast ultrasound over 15 minutes. AIM 2: Participants undergo breast ultrasounds over 15 minutes before starting the chemotherapy, 2 months after start of chemotherapy, and after the completion of chemotherapy before surgery. Participants may also undergo breast ultrasounds at 2 weeks after start of chemotherapy and 1 month after start of chemotherapy. AIM 3: Patients with suspicious breast masses or known breast cancer who are scheduled for axillary lymph node biopsy undergo ultrasound over 15 minutes at the same visit of the breast mass study.

Official Title
-----------------
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

Conditions
-----------------
Breast Carcinoma, Breast Neoplasm

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AIM 1: Patient volunteers, ages >= 18 with suspicious breast masses scheduled for breast biopsy, or at least two weeks or more after breast biopsy AIM 2: Patient volunteers, ages >= 18 who have biopsy proven breast cancer and are going under neoadjuvant chemotherapy and had their baseline MRI and/or ultrasound Exclusion Criteria: Patients with breast implants, mastectomy or any condition that does not allow proper use of ultrasound (U.S.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (ultrasound)<br>AIM 1: Participants undergo a breast ultrasound over 15 minutes. AIM 2: Participants undergo breast ultrasounds over 15 minutes before starting the chemotherapy, 2 months after start of chemotherapy, and after the completion of chemotherapy before surgery. Participants may also undergo breast ultrasounds at 2 weeks after start of chemotherapy and 1 month after start of chemotherapy. AIM 3: Patients with suspicious breast masses or known breast cancer who are scheduled for axillary lymph node biopsy undergo ultrasound over 15 minutes at the same visit of the breast mass study. | Procedure: Ultrasound<br>* Undergo breast ultrasound<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of ultrasound in detection of breast cancer | Will be reported including 95% confidence intervals derived from the cross-validation procedure. | Up to study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in prediction of treatment response | Morphological parameters of the lesion's microvasculature will be assessed at each visit. Correlation between changes in the morphological parameters and the clinical measure of lesion size will be assessed. Analyses will be done by time periods separately, change from pre-chemotherapy to halfway through chemotherapy and again from pre to post-chemotherapy. The diagnostic accuracy estimates will be reported along with 95% confidence interval. Univariate associations between changes in microvasculature parameters assessments during a time period with the magnetic resonance imaging (MRI) assessment for change in the same time period will be assessed using logistic regression, reporting the odds ratio and 95% confidence interval. Multi-variable logistic regression will be used to assess independent associations of change in assessments with MRI assessment for change. T-tests will be used to compare microvasculature information between chemotherapy responders and non-responders. | Up to study completion, an average of 1 year |