Elasticity Imaging for Breast Cancer

Overseen By Yangpei Liu, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnancy, Lactation, Breast implants, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique called Harmonic Motion Imaging (HMI) to predict breast cancer's response to pre-surgery chemotherapy. The goal is to determine if changes in HMI readings can indicate early treatment effectiveness. Eligible participants are women with early-stage invasive breast cancer, a tumor size of at least 4 mm, and scheduled to receive chemotherapy before surgery. As an unphased trial, this study allows patients to contribute to innovative research that could enhance early detection of treatment effectiveness.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for breast cancer patients?

Research has shown that Harmonic Motion Imaging (HMI) is a promising method for detecting and studying tumors. Studies have demonstrated that HMI can help distinguish between benign (non-cancerous) and malignant (cancerous) breast tumors by measuring tissue movement. This technique uses gentle vibrations to map tissue stiffness, providing important details about the tumor.

Various research settings have studied the safety of HMI. It is a non-invasive imaging method, meaning it doesn't involve cuts or injections. While detailed reports on side effects specifically for HMI are limited, the process resembles an ultrasound, which is generally considered safe and well-tolerated in medical practice.

Although this study is in the "Not Applicable" phase, indicating it might not yet have complete safety data for humans, existing research suggests that HMI is a low-risk procedure with no known significant side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques for breast cancer, which often rely on detecting structural changes, harmonic motion imaging (HMI) focuses on the mechanical properties of tissues. This method uses sound waves to assess tissue stiffness, which can be a more direct indicator of tumor presence and response to treatment. Researchers are excited about HMI because it has the potential to provide more accurate and earlier detection of how well a tumor is responding to chemotherapy, possibly leading to more personalized and timely treatment adjustments.

What evidence suggests that Harmonic Motion Imaging is effective for predicting breast cancer response to chemotherapy?

Research has shown that Harmonic Motion Imaging (HMI), which participants in this trial will receive, might help predict breast cancer's response to chemotherapy. Studies have found that HMI can differentiate breast tumors based on their movement when exposed to sound waves, as cancerous tissue is usually stiffer than normal tissue. Evidence suggests that tumors responding well to treatment often become smaller and less stiff. By measuring these changes, HMI could help determine the chemotherapy's effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Elisa Konofagou, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with invasive breast cancer of at least 4 mm in size, who are eligible for neoadjuvant systemic therapy. It's not suitable for pregnant or breastfeeding women, those with breast implants, or a history of laser/radiation therapy to the affected breast.

Inclusion Criteria

Women who are 18 years old or older.

Your doctor thinks you should get medicine before surgery, and they will decide the right amount and timing for you.

You have invasive breast cancer, and the size of the main tumor in the breast is at least 4 millimeters.

Exclusion Criteria

Patient is pregnant or lactating

You have breast implants.

You have had laser or radiation therapy on the affected breast in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant chemotherapy and undergo Harmonic Motion Imaging (HMI) to predict response

28 weeks

Regular visits for chemotherapy and imaging assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Harmonic motion imaging

Trial Overview The study is testing Harmonic Motion Imaging (HMI), a new imaging technique designed to predict how early-stage breast cancer responds to chemotherapy given before surgery (neoadjuvant chemotherapy).

How Is the Trial Designed?

Group I: HMI Group Experimental Treatment 1 Intervention

Women undergoing standard neoadjuvant chemotherapy for breast cancer

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Harmonic motion imaging (HMI) is an effective technique for assessing tissue mechanical properties, showing promise in tumor detection and monitoring treatment procedures, with an analytical model demonstrating high accuracy compared to finite element models.

The analytical model for HMI offers faster computation for real-time imaging applications, although it has limitations regarding tissue homogeneity and dimensionality, while finite element models can adapt to more complex tissue geometries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analytical model of full-field displacement and strain induced by amplitude-modulated focused ultrasound in harmonic motion imaging. McGarry, MDJ., Campo, A., Payen, T., et al.[2022]

In a study involving 17 patients with no liver disease, using filter-based harmonic ultrasound imaging significantly improved the measurement of liver elasticity, showing a 2.9-fold increase in maximum shear wave displacement.

The use of harmonic imaging also led to a 17.6% increase in the success rate of shear wave velocity measurements, indicating that this technique enhances the accuracy and reliability of assessing liver fibrosis non-invasively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Shear Wave Motion Detection Using Harmonic Imaging in Healthy Human Liver. Amador, C., Song, P., Meixner, DD., et al.[2018]

Elasticity imaging in ultrasound provides a way to differentiate soft tissues based on their mechanical properties, such as elasticity and viscosity, which can help identify normal anatomy and pathological lesions more effectively than conventional imaging that relies on echogenicity.

Current commercial elasticity imaging methods, including quasi-static and shear wave imaging, utilize mechanical excitation to assess tissue response, enhancing the diagnostic capabilities of ultrasound by revealing differences in tissue stiffness that may not be visible through standard imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Shiina, T., Nightingale, KR., Palmeri, ML., et al.[2022]

In a study involving 54 patients, ultrasound elasticity imaging using controlled force measurements showed that malignant breast lesions exhibited greater strain differences compared to benign lesions, particularly at higher compression forces (2-6N).

The research demonstrated that a power law model effectively characterized the nonlinear elastic response of breast tissue, allowing for improved differentiation between malignant and benign lesions, which could enhance non-invasive cancer detection methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Force-Matched Approach to Large-Strain Nonlinearity in Elasticity Imaging for Breast Lesion Characterization. Rosen, DP., Nayak, R., Wang, Y., et al.[2023]

Ultrasound elastography is a noninvasive imaging technique that estimates tissue elasticity, which can help differentiate and characterize various malignant tumors, including those in the breast, prostate, and liver.

This technique has been particularly effective in assessing liver fibrosis in patients with diffuse liver diseases, indicating its potential to enhance ultrasound diagnostics in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time sonoelastography - a new application in the field of liver disease. Gheorghe, L., Iacob, S., Gheorghe, C.[2016]

Harmonic motion imaging (HMI) effectively differentiates between benign and malignant breast tumors by measuring their stiffness and displacement, with malignant tumors showing lower displacement (1.1 µm) compared to benign tumors (3.6 µm) and surrounding tissue (6.4 µm).

The study involved 10 female subjects and demonstrated a strong correlation between in vivo HMI results and post-surgical ex vivo findings, suggesting that HMI could enhance diagnostic accuracy in clinical settings when used alongside traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmonic motion imaging of human breast masses: an in vivo clinical feasibility. Saharkhiz, N., Ha, R., Taback, B., et al.[2022]

Using elevated mechanical index (MI) values in harmonic imaging techniques for hepatic shear wave elasticity imaging significantly improved the yield of shear wave speed measurements by 27% at a depth of 5 cm, especially in challenging cases.

High-MI tracking enhanced the quality of imaging data by increasing the signal-to-noise ratio and reducing motion jitter, indicating a clinical benefit in using higher acoustic output for better diagnostic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Benefit of Elevated Acoustic Output in Harmonic Motion Estimation in Ultrasonic Shear Wave Elasticity Imaging. Deng, Y., Palmeri, ML., Rouze, NC., et al.[2019]

Ultrasound elasticity imaging is a promising technique that measures the stiffness and viscosity of soft tissues, helping to differentiate between normal and diseased tissues based on their mechanical properties.

This imaging method is transitioning from research to clinical use, with commercial applications starting to emerge, indicating its potential as a valuable diagnostic tool in medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What challenges must be overcome before ultrasound elasticity imaging is ready for the clinic? Palmeri, ML., Nightingale, KR.[2021]

A new ultrasonography technique is being developed to estimate the viscoelastic properties of tissue, providing real-time images of mechanical strain that can serve as a surrogate for manual palpation.

In studies of breast lesions, invasive ductal carcinomas appear significantly larger on elasticity images compared to B-mode images, while fibroadenomas and cysts show similar sizes on both types, indicating potential for improved diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAPM/RSNA physics tutorial for residents: topics in US: beyond the basics: elasticity imaging with US. Hall, TJ.[2016]

The real-time elasticity imaging (EI) ultrasound system demonstrated a sensitivity of 100% and specificity of 95% in distinguishing between benign and malignant breast lesions in a study of 208 patients with 251 lesions.

This technique could significantly reduce unnecessary breast biopsies by accurately identifying benign lesions, as it correctly classified 187 out of 197 benign lesions based on the EI/B-mode ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time ultrasound elasticity of the breast: initial clinical results. Barr, RG.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4212938/

Harmonic Motion Imaging (HMI) for Tumor ... In this paper, the application of Harmonic Motion Imaging (HMI) for tumor detection based on its stiffness as well as its relevance in thermal treatment is ...

2. nature.com nature.com/articles/s41598-020-71960-5

Harmonic motion imaging of human breast masses We studied the in vivo feasibility of a clinical HMI system to differentiate breast tumors based on their relative HMI displacements, in human subjects.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562924003661

Amplitude-Modulation Frequency Optimization for ... Results indicated that responsive tumors had at least a 50% decrease in volume [3,9] and 20%–60% decrease in stiffness [4,6]. Ultrasound, requiring no contrast ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12475938/

A Multimodal Ultrasound-Driven Approach for Automated ... Harmonic Motion Imaging (HMI) is an ultrasound elasticity imaging method that measures the mechanical properties of tissue using ...

5. academiccommons.columbia.edu academiccommons.columbia.edu/doi/10.7916/ht44-9m25

Development and optimization of a clinical harmonic motion ... Harmonic Motion Imaging (HMI) is an elastography method, in which an oscillatory radiation force is used to generate tissue displacement at ...

6. withpower.com withpower.com/trial/phase-breast-neoplasms-3-2021-45ebd

Elasticity Imaging for Breast Cancer Research shows that Harmonic Motion Imaging (HMI) can help differentiate between benign and malignant breast tumors by measuring how much the tissue moves when ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8136334/

Feasibility of Harmonic Motion Imaging Using A Single ... These results indicate that ST-HMI is feasible and can assess the mechanical properties of tissue via harmonic motion generation and tracking at ARF-ROE.

8. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-016-0707-3

Tumor characterization and treatment monitoring of ... We have developed harmonic motion imaging (HMI), which can be used seamlessly in conjunction with HIFU for tumor ablation monitoring, namely ...