Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

NCT04799535 | Recruiting FDA Device

• 3 other identifiers: 19-003028NCI-2021-01733R01CA239548
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy in prediction of treatment response

  Up to study completion, an average of 1 year

Other Outcomes (4)

• Specificity of ultrasound in prediction of NUMMA parameters - tortuosity

  Up to study completion, an average of 1 year

• Specificity of ultrasound in prediction of NUMMA parameters - vessel diameter

  Up to study completion, an average of 1 year

• Specificity of ultrasound in prediction of NUMMA parameters - numbers of vessel segments

  Up to study completion, an average of 1 year

Study Arms (1)

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

Interventions

Ultrasound PROCEDURE

Undergo breast ultrasound

Observational (ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with breast implants or any condition that does not allow proper use of ultrasound (US)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Azra Alizad, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: September 1, 2019
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): November 29, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)