Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

Breast Carcinoma Clinical Trial

Official title:

Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799535
• Other study ID #: 19-003028
• Secondary ID: NCI-2021-0173319
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: November 29, 2028

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 29, 2028
• Est. primary completion date: November 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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.)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasm
• Breast Neoplasms

Intervention

Procedure:
• Ultrasound
Undergo breast ultrasound

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Specificity of ultrasound in prediction of NUMMA parameters	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
Other	Specificity of ultrasound in prediction of NUMMA parameters	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
Other	Specificity of ultrasound in prediction of NUMMA parameters	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
Other	Specificity of ultrasound in prediction of NUMMA parameters	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
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials