NCT04925817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

May 25, 2021

Last Update Submit

June 6, 2024

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (8)

  • Ultrasound diagnostic accuracy using McNemar's test

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

    Up to 1 year

  • Ultrasound parameters sensitivity using McNemar's test

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

    Up to 1 year

  • Ultrasound parameters specificity using McNemar's test

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

    Up to 1 year

  • Ultrasound parameters positive predictive value using McNemar's test

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

    Up to 1 year

  • Ultrasound parameters negative predictive value using McNemar's test

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

    Up to 1 year

  • Ultrasound parameters accuracy using McNemar's test

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

    Up to 1 year

  • Ultrasound parameters calculated by McNemar's test

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

    Up to 1 year

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

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

    Up to 1 year

Study Arms (1)

Diagnostic (ultrasound microvessel imaging)

EXPERIMENTAL

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

Other: Electronic Health Record ReviewProcedure: Ultrasound Microvessel Imaging

Interventions

Electronic Health Record ReviewOTHER

Medical record reviewed

Diagnostic (ultrasound microvessel imaging)
Ultrasound Microvessel ImagingPROCEDURE

Undergo 3D ultrasound microvessel imaging

Also known as: 3D Ultrasound Microvessel Imaging, UMI
Diagnostic (ultrasound microvessel imaging)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shigao Chen, Ph.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 14, 2021

Study Start

August 19, 2021

Primary Completion

May 18, 2023

Study Completion

May 18, 2023

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations

US(1)