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3D Ultrasound Breast Imaging

Primary Purpose

Breast Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GE Logiq E10 clinical ultrasound scanner
Verasonics research scanner
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult women, ≥ 18 years of age.
  • Breast lesion and are scheduled for clinically-indicated biopsy.

Exclusion Criteria:

  • < 18 years of age.
  • Previous breast surgery or breast implant.
  • Lacking capacity to consent.
  • Pregnant or lactating.
  • Receiving cancer therapy such as chemotherapy or radiation therapy.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clinically indicated breast tumor biopsy

Arm Description

Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed

Outcomes

Primary Outcome Measures

BI-RADS Score
BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.

Secondary Outcome Measures

Full Information

First Posted
December 30, 2020
Last Updated
January 4, 2023
Sponsor
Mayo Clinic
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04692818
Brief Title
3D Ultrasound Breast Imaging
Official Title
3D Multimodal Ultrasound Imaging for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Tumor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinically indicated breast tumor biopsy
Arm Type
Experimental
Arm Description
Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed
Intervention Type
Diagnostic Test
Intervention Name(s)
GE Logiq E10 clinical ultrasound scanner
Intervention Description
2D B-mode, Doppler, and shear wave elastography images of the lesion
Intervention Type
Diagnostic Test
Intervention Name(s)
Verasonics research scanner
Intervention Description
3D B-mode imaging, microvessel imaging, and shear wave elastography
Primary Outcome Measure Information:
Title
BI-RADS Score
Description
BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult women, ≥ 18 years of age. Breast lesion and are scheduled for clinically-indicated biopsy. Exclusion Criteria: < 18 years of age. Previous breast surgery or breast implant. Lacking capacity to consent. Pregnant or lactating. Receiving cancer therapy such as chemotherapy or radiation therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigao Chen
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobbie Ott
Phone
507-293-0922
Email
ott.bobbie@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

3D Ultrasound Breast Imaging

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