3D Ultrasound Imaging for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Disqualifiers: Prisoners, Lacking capacity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D ultrasound technology to evaluate its effectiveness in examining lymph nodes in breast cancer patients. Ultrasound uses sound waves to create images of the body's interior, and the study aims to determine if the 3D version provides better information. The trial includes patients who have undergone a lymph node biopsy or had a clip placed as part of their standard breast cancer care. As an Early Phase 1 trial, this research focuses on understanding how the new 3D ultrasound technology functions in people, offering participants an opportunity to contribute to groundbreaking advancements in breast cancer diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 3D ultrasound imaging is safe for evaluating lymph nodes in breast cancer patients?

Research shows that 3D ultrasound (3D-US) imaging is generally safe for checking breast cancer. Previous studies on similar ultrasound methods found that people usually tolerate them well. These studies reported no major negative side effects from the imaging itself. Since 3D ultrasound is already used in other breast exams, it suggests safety. However, because this trial is in its early stages, gathering more safety information as research progresses remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D ultrasound imaging for breast cancer because it offers a new, non-invasive way to visualize breast tissue and lymph nodes in three dimensions. Unlike traditional 2D mammograms or ultrasounds, which can sometimes miss small abnormalities, 3D ultrasound provides a more detailed and comprehensive view, potentially improving early detection and diagnosis. Additionally, it allows doctors to monitor changes in lymph nodes during chemotherapy, offering a clearer picture of how well the treatment is working before surgery. This approach aims to enhance accuracy and reduce the need for more invasive procedures.

What evidence suggests that this 3D ultrasound imaging is effective for evaluating lymph nodes in breast cancer?

Research shows that 3D ultrasound (3D-US), which participants in this trial will undergo, can help detect breast cancer. Studies have found that 3D automated breast ultrasound (ABUS) improves cancer detection, especially in women with dense breast tissue. One study reported a significant increase in finding cancers that mammograms missed, with a 23.9% rise in sensitivity. Additionally, early results using computer techniques with 3D ultrasound demonstrated a 98% accuracy in identifying cancerous tissue. These findings suggest that 3D-US could be a useful tool for checking lymph nodes in breast cancer patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Shigao D Chen, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This clinical trial is for women over the age of 18 who have breast cancer and are scheduled to undergo a biopsy of their axillary lymph nodes, which are located near the armpits. It's not open to prisoners or adults unable to consent.

Inclusion Criteria

I am a woman with breast cancer and will have a lymph node biopsy.

Exclusion Criteria

I am not a prisoner and can make my own health decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Patients undergo 3D-US imaging to evaluate lymph nodes and compare with 2D-US

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• 3D Ultrasound

Trial Overview The study is testing a new imaging technology called 3D ultrasound (3D-US) to see how well it can evaluate axillary lymph nodes in patients with breast cancer compared to standard imaging methods.

How Is the Trial Designed?

Group I: Diagnostic (3D-US) Experimental Treatment 1 Intervention

Patients undergo 3D-US on study. Patients who have a lymph node clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

3D Ultrasound is already approved in United States, European Union for the following indications:

Approved in United States as 3D Ultrasound for:

• Evaluation of lymph nodes in breast cancer

Approved in European Union as 3D Ultrasound for:

• Evaluation of lymph nodes in breast cancer

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 141 patients with 150 solid breast masses, 3D ultrasonography (US) demonstrated comparable diagnostic performance to 2D US in differentiating between benign and malignant lesions, with both methods achieving high sensitivity rates.

While 3D US showed equal or slightly improved specificity and negative predictive values compared to 2D US, the differences were not statistically significant, suggesting that both imaging techniques are effective for breast mass evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiating benign from malignant solid breast masses: comparison of two-dimensional and three-dimensional US. Cho, N., Moon, WK., Cha, JH., et al.[2016]

The study analyzed 221 breast tumors using 3D ultrasonography and found that the convergence sign is significantly associated with various prognostic factors, including smaller tumor size and positive hormone receptor status, indicating its potential as a predictive marker for breast cancer prognosis.

Irregular tumor margins observed in 3D ultrasonography were linked to axillary lymph node metastases and negative C-erb-B2 expression, suggesting that these imaging characteristics can help inform treatment decisions for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasonography for the prediction of breast cancer prognosis. Xu, G., Han, T., Yao, MH., et al.[2016]

Three-dimensional (3D) ultrasound provides different characteristics for breast lesions compared to conventional two-dimensional (2D) ultrasound, particularly highlighting the retraction phenomenon as a significant factor in lesion characterization.

Despite the differences in ultrasound features, the diagnostic accuracy of 3D and 2D ultrasound is nearly identical, suggesting that 3D ultrasound could be a valuable adjunct to 2D ultrasound in breast imaging, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasound for the assessment of breast lesions. Watermann, DO., Földi, M., Hanjalic-Beck, A., et al.[2019]

Three-dimensional (3-D) ultrasound provides a comprehensive and automated scanning of the breast, which enhances the reliability of reviews and follow-ups compared to traditional ultrasound methods.

This technique has the potential to be integrated into routine radiological practices and could be beneficial for population screening programs for breast cancer, improving early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[3-D ultrasound of the breast: less dependent on the investigator]. de Jong, MD., Dubelaar, IJ., Fassaert, TA., et al.[2016]

Three-dimensional ultrasound (3D-US) is a reproducible imaging technique that has shown potential in assessing gynecological cancers, particularly in estimating endometrial volume for predicting endometrial cancer.

While 3D-US is not superior to conventional 2D ultrasound for predicting ovarian cancer, it may provide useful insights into tumor vascularity in certain cases, especially for endometrial and cervical cancers, indicating its potential role in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasound for assessing women with gynecological cancer: a systematic review. Alcázar, JL., Jurado, M.[2018]

3D ultrasonography provided superior image quality compared to 2D ultrasonography when evaluating 507 solid breast masses, particularly for larger masses over 10 mm.

Despite the improved image quality with 3D imaging, there was no significant difference in diagnostic accuracy for breast cancer detection when compared to 2D imaging, indicating that both methods are equally effective in diagnosing breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of 2D and 3D ultrasonography for evaluation of solid breast masses. Cho, KR., Seo, BK., Lee, JY., et al.[2016]

In a study of 85 women with invasive ductal carcinoma, the retraction pattern observed in 3D ultrasound was found to be a significant predictor of smaller tumor size, lower histological grade, and positive estrogen or progesterone receptor status, indicating a better prognosis.

The intra-tumor vascularization index (VI) measured by 3D ultrasound correlated with higher histological grades and microvessel density, suggesting that increased vascularization may indicate more aggressive tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between three-dimensional ultrasound features and pathological prognostic factors in breast cancer. Jiang, J., Chen, YQ., Xu, YZ., et al.[2021]

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. 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 ...

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

Comparison of supplemental breast cancer imaging ... This is the first randomised controlled trial to compare supplemental imaging techniques in women of average population risk with dense breasts.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211568419300713

Three-dimensional automated breast ultrasound The study revealed a significant increase in the detection rate of breast cancer by 3D ABUS (absolute increase in sensitivity: 23.9% in mammography-negative ...

5. rochester.edu rochester.edu/newscenter/breast-cancer-diagnosis-machine-learning-ultrasound-555952/

Better breast cancer diagnosis through machine-learning ... Better breast cancer diagnosis through machine-learning ultrasound · Early results show 98 percent accuracy in predicting malignant tissue.

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

FDA - Summary of Safety and Effectiveness Data (SSED) The sensitivity of mammography is reduced by 36% to 38% for women with dense breast tissue in comparison to the sensitivity of mammography for ...

7. 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 ...

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.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04692818

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 ...