Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm; Breast Carcinoma
• Intervention / Treatment: Procedure: Ultrasound

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.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Azra Alizad, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Volunteers for Aim 1 are without a history of mastectomy or implants, and at least a single suspicious breast mass that is scheduled for biopsy. Volunteers for Aim 2 have biopsy proven breast cancer and are scheduled for chemotherapy and/or endocrine therapy.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (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.

Procedure: Ultrasound; Undergo breast ultrasound

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of ultrasound in prediction of NUMMA parameters - tortuosity	The diagnostic accuracy of the NUMMA parameters, such as tortuosity will be assessed using an automated quantification tool. Logistic regression models will examine these collective parameters as predictors of metastatic axillary lymph node in breast cancer patients. Area under the receiver operating characteristic curve (area under the curve) will be examined for univariate and multivariable models. Statistical evaluation of the performance of 2 dimensional (D) and 3D images will be performed with the McNemar's test separately for metastatic and reactive lymph nodes.	Up to study completion, an average of 1 year
Specificity of ultrasound in prediction of NUMMA parameters - vessel diameter	The diagnostic accuracy of the NUMMA parameters, such as vessel diameter will be assessed using an automated quantification tool. Logistic regression models will examine these collective parameters as predictors of metastatic axillary lymph node in breast cancer patients. Area under the receiver operating characteristic curve (area under the curve) will be examined for univariate and multivariable models. Statistical evaluation of the performance of 2 dimensional (D) and 3D images will be performed with the McNemar's test separately for metastatic and reactive lymph nodes.	Up to study completion, an average of 1 year
Specificity of ultrasound in prediction of NUMMA parameters - numbers of vessel segments	The diagnostic accuracy of the NUMMA parameters, such as numbers of vessel segments will be assessed using an automated quantification tool. Logistic regression models will examine these collective parameters as predictors of metastatic axillary lymph node in breast cancer patients. Area under the receiver operating characteristic curve (area under the curve) will be examined for univariate and multivariable models. Statistical evaluation of the performance of 2 dimensional (D) and 3D images will be performed with the McNemar's test separately for metastatic and reactive lymph nodes.	Up to study completion, an average of 1 year
Specificity of ultrasound in prediction of NUMMA parameters - vessel density	The diagnostic accuracy of the NUMMA parameters, such as vessel density will be assessed using an automated quantification tool. Logistic regression models will examine these collective parameters as predictors of metastatic axillary lymph node in breast cancer patients. Area under the receiver operating characteristic curve (area under the curve) will be examined for univariate and multivariable models. Statistical evaluation of the performance of 2 dimensional (D) and 3D images will be performed with the McNemar's test separately for metastatic and reactive lymph nodes.	Up to study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Azra Alizad, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): November 29, 2027

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: 19-003028 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2021-01733 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA239548 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No