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Completed

NCT Number: NCT04925817

3D Ultrasound Microvessel Imaging for Breast Masses

This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

PRIMARY OBJECTIVES:

I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.

OUTLINE:

Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
  • Lesion size of 3 mm or larger.
  • Age 18 or greater.

Exclusion criteria

  • Women with previous breast surgery or breast implant.
  • Lacking the capacity to consent.
  • Women who are pregnant or lactating.
  • Women who are receiving cancer therapy such as chemotherapy or radiation therapy.

Treatment and study plan

Electronic Health Record Review

Other

Medical record reviewed

Ultrasound Microvessel Imaging

Procedure

Undergo 3D ultrasound microvessel imaging

Other names: 3D Ultrasound Microvessel Imaging, UMI

Primary outcomes

  1. Ultrasound diagnostic accuracy using McNemar's test

    Time frame: Up to 1 year

    Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.

  2. Ultrasound parameters sensitivity using McNemar's test

    Time frame: Up to 1 year

    Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.

  3. Ultrasound parameters specificity using McNemar's test

    Time frame: Up to 1 year

    Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.

  4. Ultrasound parameters positive predictive value using McNemar's test

    Time frame: Up to 1 year

    Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

  5. Ultrasound parameters negative predictive value using McNemar's test

    Time frame: Up to 1 year

    Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .

  6. Ultrasound parameters accuracy using McNemar's test

    Time frame: Up to 1 year

    Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

  7. Ultrasound parameters calculated by McNemar's test

    Time frame: Up to 1 year

    Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

  8. Ultrasound parameters vs. Breast Image Reporting using McNemar's test

    Time frame: Up to 1 year

    Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
Jun 7, 2024

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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