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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 3D Ultrasound Imaging for Breast Cancer?

Research shows that 3D ultrasound is more accurate than traditional 2D ultrasound in diagnosing breast lesions and differentiating between benign (non-cancerous) and malignant (cancerous) breast masses, which can help in predicting breast cancer prognosis. ^{1 2 3 4 5}

What makes 3D Ultrasound Imaging unique for breast cancer treatment?

3D Ultrasound Imaging is unique because it automatically scans almost the entire breast, reducing the subjective nature of conventional ultrasound and allowing for more reliable reviews and follow-ups. This technique can be used in routine radiological practice and potentially in population screening programs for breast cancer. ^{1 2 3 6 7}

What is the purpose of this trial?

This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.

Research Team

Shigao D Chen, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Cyprus pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasonography for the prediction of breast cancer prognosis. [2016]

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

Three-dimensional ultrasound for the assessment of breast lesions. [2019]

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

Correlation between three-dimensional ultrasound features and pathological prognostic factors in breast cancer. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

A comparative study of 2D and 3D ultrasonography for evaluation of solid breast masses. [2016]

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

Differentiating benign from malignant solid breast masses: comparison of two-dimensional and three-dimensional US. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[3-D ultrasound of the breast: less dependent on the investigator]. [2016]

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

Three-dimensional ultrasound for assessing women with gynecological cancer: a systematic review. [2018]