Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04799535
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound — PROCEDURE
    Undergo breast ultrasound

Study Details

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.

Key Dates

Start date
Sep 1, 2019
Status verified
Jan 2026
Primary completion
Nov 29, 2027
Completion
Nov 29, 2027

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Specificity of ultrasound in detection of breast cancer [ Time Frame: Up to study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Azra Alizad, M.D. (PRINCIPAL_INVESTIGATOR)

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