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3D Ultrasound Imaging for Breast Cancer

Phase < 1
Waitlist Available
Led By Shigao D 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
Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
Age 18 or greater.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial uses 3D ultrasound microvessel imaging to study how well it works for diagnosing breast mass. So far, it's shown to be more effective than current methods.

Who is the study for?
This trial is for women aged 18 or older with a breast mass of at least 3 mm, who are scheduled for an ultrasound-guided biopsy. It's not suitable for those with previous breast surgery or implants, currently undergoing cancer therapy, pregnant or lactating women, or those unable to consent.Check my eligibility
What is being tested?
The study is testing the effectiveness of a new technology called 3D ultrasound microvessel imaging in diagnosing breast masses without contrast agents. This non-invasive method could potentially improve cancer diagnosis and reduce unnecessary biopsies on benign tumors.See study design
What are the potential side effects?
Since this trial involves non-invasive imaging that doesn't use contrast agents and only includes electronic health record review and ultrasound imaging, there are minimal expected side effects compared to invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman scheduled for a biopsy due to a solid breast lesion.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ultrasound diagnostic accuracy using McNemar's test
Ultrasound parameters accuracy using McNemar's test
Ultrasound parameters calculated by McNemar's test
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (ultrasound microvessel imaging)Experimental Treatment2 Interventions
Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,033 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,592 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Shigao D Chen, Ph.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Ultrasound Microvessel Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04925817 — Phase < 1
Breast Cancer Research Study Groups: Diagnostic (ultrasound microvessel imaging)
Breast Cancer Clinical Trial 2023: Ultrasound Microvessel Imaging Highlights & Side Effects. Trial Name: NCT04925817 — Phase < 1
Ultrasound Microvessel Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925817 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any enrolment slots still available for this experiment?

"Affirmative. Clinicaltrials.gov documents that this trial is currently enrolling participants, with the initial posting on August 19th 2021 and a recent update made May 12th 2022. The study seeks to recruit 50 patients from 1 medical centre."

Answered by AI

What is the participant size for this investigation?

"Affirmative, the information present on clinicaltrials.gov points towards this trial still being open for recruitment of patients. The original posting was made on August 19th 2021 and it has since been updated as recently as May 12th 2022. Solely 1 site is necessary to recruit 50 people in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
3D Ultrasound Microvessel Imaging for Breast Masses
2021. "3D Ultrasound Microvessel Imaging for Breast Masses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04925817.
~14 spots leftby Apr 2025
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