Clinical trial NCT04799535: Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Official title: Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Breast Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-16
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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/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)

Primary outcomes:
measure: Specificity of ultrasound in detection of breast cancer
timeFrame: Up to study completion, an average of 1 year
Secondary outcomes:
measure: Accuracy in prediction of treatment response
timeFrame: Up to study completion, an average of 1 year
Other outcomes:
measure: Specificity of ultrasound in prediction of NUMMA parameters - tortuosity
timeFrame: Up to study completion, an average of 1 year
measure: Specificity of ultrasound in prediction of NUMMA parameters - vessel diameter
timeFrame: Up to study completion, an average of 1 year
measure: Specificity of ultrasound in prediction of NUMMA parameters - numbers of vessel segments
timeFrame: Up to study completion, an average of 1 year
measure: Specificity of ultrasound in prediction of NUMMA parameters - vessel density
timeFrame: Up to study completion, an average of 1 year
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Azra Alizad, M.D.
role: PRINCIPAL_INVESTIGATOR
References: