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3D Ultrasound Imaging for Breast Cancer Detection

N/A
Recruiting
Led By Shigao Chen, Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult women, ≥ 18 years of age.
Be older than 18 years old
Must not have
< 18 years of age.
Lacking capacity to consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new ultrasound method to better diagnose breast lumps by creating clearer and more detailed images.

Who is the study for?
This trial is for adult women over 18 with a breast lesion who are scheduled for a biopsy. It's not open to those under 18, anyone with previous breast surgery or implants, those unable to consent, pregnant or breastfeeding women, or patients currently undergoing cancer treatments.
What is being tested?
The study is testing the effectiveness of a new ultrasound imaging method using two different scanners: the GE Logiq E10 and the Verasonics research scanner. The goal is to see how well they diagnose breast masses compared to current methods.
What are the potential side effects?
Ultrasound scanning is generally safe and does not have significant side effects. However, there might be minor discomfort due to pressure from the ultrasound probe during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.
Select...
I am unable to understand or make decisions about my treatment.
Select...
I have had breast surgery or have a breast implant.
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I am currently undergoing cancer treatment like chemotherapy or radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BI-RADS Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Clinically indicated breast tumor biopsyExperimental Treatment2 Interventions
Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include surgery, which physically removes the tumor; radiation therapy, which uses high-energy rays to kill cancer cells; chemotherapy, which uses drugs to destroy rapidly dividing cells; hormone therapy, which blocks hormones that fuel certain cancers; and targeted therapy, which attacks specific molecules involved in cancer growth. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan, especially when new diagnostic tools like 3D ultrasound imaging can provide more accurate detection and characterization of breast masses, potentially leading to more personalized and effective treatment strategies.
Impact of modern personalized treatment of breast cancer on surgical attitude and outcomes.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,224 Total Patients Enrolled
84 Trials studying Breast Cancer
14,796 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
910 Previous Clinical Trials
333,606 Total Patients Enrolled
38 Trials studying Breast Cancer
103,344 Patients Enrolled for Breast Cancer
Shigao Chen, Ph.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

GE Logiq E10 clinical ultrasound scanner Clinical Trial Eligibility Overview. Trial Name: NCT04692818 — N/A
Breast Cancer Research Study Groups: Clinically indicated breast tumor biopsy
Breast Cancer Clinical Trial 2023: GE Logiq E10 clinical ultrasound scanner Highlights & Side Effects. Trial Name: NCT04692818 — N/A
GE Logiq E10 clinical ultrasound scanner 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692818 — N/A
~3 spots leftby Dec 2024