3D Ultrasound Imaging for Breast Cancer Detection

Overseen by Christine Lee, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy, Radiation therapy

Disqualifiers: Under 18, Pregnant, Lactating, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does exclude those receiving cancer therapy like chemotherapy or radiation.

What data supports the effectiveness of the treatment 3D Ultrasound Breast Imaging for breast cancer detection?

Research shows that 3D automated breast ultrasound (ABUS) is effective in detecting breast cancer, especially in women with dense breast tissue. It improves cancer detection rates when used alongside traditional mammography and offers a non-ionizing alternative to other screening methods. ^{1 2 3 4 5}

How does 3D ultrasound imaging differ from other breast cancer detection treatments?

3D ultrasound imaging, specifically the 3D automated breast ultrasound system (3D ABUS), is unique because it provides high-resolution images with a large field of view, addressing limitations of traditional hand-held ultrasounds. It is particularly beneficial for women with dense breast tissue, offering a non-ionizing alternative to mammography and improving detection rates when used alongside mammography. ^{1 2 3 5 6}

Research Team

Shigao Chen, PhD

Principal Investigator

Mayo Clinic

Christine Lee, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 18 or older.

I have a breast lump and am scheduled for a biopsy.

Exclusion Criteria

I am under 18 years old.

Pregnant or lactating.

I am unable to understand or make decisions about my treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 3D Multimodal Ultrasound Imaging for breast mass diagnosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 3D Ultrasound Breast Imaging (Ultrasound Imaging)

Trial Overview 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.

Participant Groups

Group I: Clinically indicated breast tumor biopsy Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

Findings from Research

In a study of 1668 asymptomatic women with dense breasts, the addition of 3D automated breast ultrasound (3D ABUS) to full field digital screening mammography (FFDSM) significantly increased the breast cancer detection rate from 4.2 to 6.6 cancers per 1000 women screened.

While the combination of FFDSM and 3D ABUS improved cancer detection, it also resulted in a higher recall rate, increasing from 13.8 to 22.8 recalls per 1000 women screened, indicating a trade-off between improved detection and increased follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding 3D automated breast ultrasound to mammography screening in women with heterogeneously and extremely dense breasts: Report from a hospital-based, high-volume, single-center breast cancer screening program. Wilczek, B., Wilczek, HE., Rasouliyan, L., et al.[2022]

The 3D automated breast ultrasound system (3D ABUS) addresses key limitations of traditional ultrasound, such as variability in skill and small field of view, making it a more standardized and efficient option for breast screening.

3D ABUS is a promising non-ionizing alternative for women with dense breast tissue and has potential applications in artificial intelligence and radiomics, enhancing its role in future breast cancer research and diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic breast ultrasound: state of the art and future perspectives. Nicosia, L., Ferrari, F., Bozzini, AC., et al.[2020]

The automated 3D breast ultrasound system (SomoV™) demonstrated fair inter-rater reliability with an agreement rate of 81.6% among two examiners, indicating it can be reliably used for breast cancer screening.

When combined with mammography, SomoV™ increased the overall sensitivity for detecting breast cancer from 90.1% to 97.7%, suggesting it could significantly enhance cancer detection rates in screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners. Maier, A., Heil, J., Lauer, A., et al.[2019]

Automated breast ultrasonography (ABUS) is a promising imaging technology that enhances breast cancer detection, particularly in women with dense breast tissue, by providing standardized and reproducible three-dimensional images.

Recent studies have demonstrated ABUS's effectiveness not only in screening but also in diagnosing breast cancer, staging tumors, and evaluating responses to treatment, highlighting its versatility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Breast Ultrasonography (ABUS) in the Screening and Diagnostic Setting: Indications and Practical Use. Rella, R., Belli, P., Giuliani, M., et al.[2022]

The 3D automated breast ultrasound system (3D ABUS) enhances breast cancer detection by providing high-resolution images over a large area, making it a valuable adjunct to mammography, especially for women with dense breast tissue.

With the aid of computer-aided detection software, 3D ABUS significantly reduces interpretation time and improves diagnostic accuracy, showing promise in differentiating between malignant and benign lesions and assessing treatment response in breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional automated breast ultrasound: Technical aspects and first results. Vourtsis, A.[2020]

In a study involving 17 qualified radiologists interpreting 185 cases, the combination of full-field digital mammography (FFDM) and 3D automated breast ultrasound (ABUS) significantly improved the detection of breast cancer, with a 14% relative increase in the area under the ROC curve (AUC) from 0.72 to 0.82 (p < 0.001).

The sensitivity for detecting breast cancer increased from 57.5% with FFDM alone to 74.1% when combined with ABUS, demonstrating a 29% improvement (p < 0.001), while the overall specificity remained largely unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Breast Ultrasound in Breast Cancer Screening of Women With Dense Breasts: Reader Study of Mammography-Negative and Mammography-Positive Cancers. Giger, ML., Inciardi, MF., Edwards, A., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Adding 3D automated breast ultrasound to mammography screening in women with heterogeneously and extremely dense breasts: Report from a hospital-based, high-volume, single-center breast cancer screening program. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Automatic breast ultrasound: state of the art and future perspectives. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Automated Breast Ultrasonography (ABUS) in the Screening and Diagnostic Setting: Indications and Practical Use. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Three-dimensional automated breast ultrasound: Technical aspects and first results. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Automated Breast Ultrasound in Breast Cancer Screening of Women With Dense Breasts: Reader Study of Mammography-Negative and Mammography-Positive Cancers. [2022]