Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

Recruiting

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 and/or endocrine therapy 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 and/or endocrine therapy, 2 months after start of chemotherapy and/or endocrine therapy, and after the completion of chemotherapy and/or endocrine therapy before surgery. Participants may also undergo breast ultrasounds at 2 weeks after start of chemotherapy and/or endocrine therapy and 1 month after start of chemotherapy and/or endocrine therapy .

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.

Recruitment & Eligibility

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/or endocrine therapy had their baseline MRI and/or ultrasound

Exclusion Criteria

Patients with breast implants or any condition that does not allow proper use of ultrasound (US)

Arm && Interventions

Group	Intervention	Description
Observational (ultrasound)	Ultrasound	AIM 1: Participants undergo a breast ultrasound over 15 minutes. AIM 2: Participants undergo breast ultrasounds over 15 minutes before starting the chemotherapy and/or endocrine therapy, 2 months after start of chemotherapy and/or endocrine therapy, and after the completion of chemotherapy and/or endocrine therapy before surgery. Participants may also undergo breast ultrasounds at 2 weeks after start of chemotherapy and/or endocrine therapy and 1 month after start of chemotherapy and/or endocrine therapy. 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Accuracy in prediction of treatment response	Up to study completion, an average of 1 year	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.

Locations (1): Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States