3D Ultrasound Imaging for Breast Cancer Detection

Overseen By Bobbie Ott

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy, Radiation therapy

Disqualifiers: Under 18, Pregnant, Lactating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D ultrasound method to better detect breast masses. The goal is to evaluate how effectively this imaging technique aids in diagnosing breast tumors. It involves women with a solid breast lesion who are already scheduled for a biopsy. Women advised to undergo a biopsy due to a breast lump of at least 3mm in size may find this trial suitable.

As an unphased trial, this study provides a unique opportunity to contribute to advancements in breast cancer diagnostics.

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 prior data suggests that this ultrasound imaging method is safe for breast cancer detection?

Research has shown that 3D ultrasound breast imaging is generally safe. Studies have found that automated breast ultrasound (ABUS) reliably detects breast cancer and is already used in both screening and diagnosis. The FDA has reviewed the safety of 3D ultrasound methods, indicating a level of trust in their use.

No reports of serious side effects or risks have emerged from the imaging process itself. This technique is non-invasive, meaning it doesn't involve breaking the skin or entering the body. It functions like a regular ultrasound but provides more detailed images.

Overall, current research considers 3D ultrasound for breast imaging safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D Ultrasound Imaging for breast cancer detection because it offers a non-invasive and radiation-free alternative to traditional mammograms and biopsies. Unlike standard imaging techniques that provide only two-dimensional views, this method creates detailed 3D images of breast tissue, potentially improving accuracy in identifying tumors. The technology could lead to earlier and more precise detection of breast cancer, which is crucial for better treatment outcomes.

What evidence suggests that 3D Ultrasound Breast Imaging is effective for breast cancer detection?

Research has shown that 3D ultrasound imaging is a powerful tool for detecting breast cancer, particularly in women with dense breast tissue. Studies have found that combining 3D automated breast ultrasound (ABUS) with regular mammograms significantly improves the detection of cancers that might not appear on mammograms alone. This method effectively identifies cancers hidden on standard mammograms. Additionally, 3D ultrasound is considered a cost-effective and portable option, increasing accessibility for patients. These findings suggest that 3D ultrasound could play a crucial role in enhancing breast cancer diagnosis. Participants in this trial will undergo 3D Multimodal Ultrasound Imaging if scheduled for a clinically indicated breast tumor biopsy. ^{3 5 6 7 8}

Who Is on the Research Team?

Christine Lee, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Shigao Chen, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 3D Ultrasound Breast 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.

How Is the Trial Designed?

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

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]

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744838/

Automated 3D Ultrasound as an Adjunct to Screening ... The use of 3D Automatized Breast Ultrasonography (3D ABUS) has proven effective in detecting mammographically occult cancer in women with dense ...

2. ajronline.org ajronline.org/doi/10.2214/AJR.15.15367

Automated Breast Ultrasound in Breast Cancer Screening of ... Combining mammography with ABUS, compared with mammography alone, significantly improved readers' detection of breast cancers in women with dense breast tissue.

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00582-3/fulltext

Comparison of supplemental breast cancer imaging ... Supplemental imaging with MRI or ultrasound have both been shown to be effective in early cancer detection. A detailed search of the literature ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04692818?cond=3D%20imaging&viewType=Table&rank=7

NCT04692818 | 3D Ultrasound Breast Imaging The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass. Official Title. 3D Multimodal Ultrasound ...

5. nature.com nature.com/articles/s41598-023-41424-7

Cost-effective, portable, patient-dedicated three ... - Nature We developed and validated a cost-effective, portable, patient-dedicated three-dimensional (3D) automated breast ultrasound (ABUS) system for point-of-care ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8400952/

Pros and Cons for Automated Breast Ultrasound (ABUS) ABUS is a standardized examination with many advantages in both screening and diagnostic settings: it increases the detection rate of breast cancer, improves ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110006b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The 3D ultrasound dataset is available to the reader immediately after acquisition and at any future point in the course of a patient's care.

8. bcrf.org bcrf.org/about-breast-cancer/breast-ultrasound/

Breast Ultrasound: Everything You Need to Know | BCRF Learn about breast ultrasounds, the difference between breast ultrasound vs mammogram, what to expect during a breast ultrasound, and more from BCRF.