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NCT Number: NCT04799535

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasm Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Azra Alizad, M.D.

PRINCIPAL_INVESTIGATOR

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ultrasound

Procedure

Undergo breast ultrasound

Primary outcomes

  1. Specificity of ultrasound in detection of breast cancer

    Time frame: Up to study completion, an average of 1 year

    Will be reported including 95% confidence intervals derived from the cross-validation procedure.

Secondary outcomes

  1. Accuracy in prediction of treatment response

    Time frame: 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.

Other outcomes

  1. Specificity of ultrasound in prediction of NUMMA parameters - tortuosity

    Time frame: Up to study completion, an average of 1 year

    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.

  2. Specificity of ultrasound in prediction of NUMMA parameters - vessel diameter

    Time frame: Up to study completion, an average of 1 year

    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.

  3. Specificity of ultrasound in prediction of NUMMA parameters - numbers of vessel segments

    Time frame: Up to study completion, an average of 1 year

    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.

  4. Specificity of ultrasound in prediction of NUMMA parameters - vessel density

    Time frame: Up to study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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