HMI-guided Focused Ultrasound for Breast Cancer

Overseen By Xiaoyue J Li, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnancy, Breast implants, Prior radiation, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for benign and early-stage breast cancer using focused ultrasound, guided by Harmonic Motion Imaging (HMI). The goal is to determine if this method can effectively target and treat tumor areas without affecting surrounding tissue. Women with fibroadenoma or early-stage breast cancer who plan to undergo tumor surgery might be suitable for this study. Participants will have part of their tumor treated with this focused ultrasound technique, followed by imaging to assess the results. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

Do I have to stop taking 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 method is safe for breast cancer treatment?

Research has shown that Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) is generally well-tolerated in clinical settings. Patients who have undergone similar procedures have demonstrated that this method can safely target and treat tumors. In earlier studies, researchers used focused ultrasound to destroy specific parts of tumors, and the results were promising with few side effects.

Evidence from these studies indicates that the treatment effectively monitors changes in tumors during the procedure. This ensures that only the target area is affected, reducing the risk of harming healthy tissue. Adverse events have been rare and mild, with no serious safety concerns reported. This suggests that HMIgFUS is a safe option for patients with non-cancerous and early-stage breast cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) for breast cancer because it offers a targeted and non-invasive alternative to traditional treatments like surgery, chemotherapy, or radiation. Unlike these standard options, HMIgFUS uses ultrasound to precisely ablate only the central portion of a tumor while leaving surrounding tissues intact. This method could potentially reduce side effects and improve recovery times, making treatment less taxing on patients. Additionally, the use of Harmonic Motion Imaging allows for real-time monitoring, ensuring precise delivery and effectiveness during the procedure.

What evidence suggests that HMI-guided focused ultrasound is effective for breast cancer?

Studies have shown that Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS), the treatment tested in this trial, is a promising approach for breast cancer. Research indicates that HMI can effectively measure the stiffness of breast tumors, aiding in more accurate targeting. Previous studies found both non-cancerous and cancerous tumors to be stiffer than surrounding tissue, suggesting that HMI can effectively guide ultrasound treatment. The technique uses ultrasound to monitor and adjust the treatment process, aiming to improve success rates in removing cancerous tissue. Early findings suggest that using HMI during focused ultrasound can ensure precise targeting, potentially leading to better outcomes for patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Elisa Konofagou, PhD

Principal Investigator

Professor of Biomedical Engineering

Are You a Good Fit for This Trial?

This trial is for women over 18 with benign tumors or early-stage, non-metastatic breast cancer. Participants should be scheduled for surgical tumor removal and have not had thermal ablation, laser, or radiation therapy on the affected breast. Women with breast implants or who are pregnant/breastfeeding cannot join.

Inclusion Criteria

I am a woman aged 18 or older.

I have a benign tumor or early-stage breast cancer without lymph node involvement.

My tumor is set to be surgically removed, and it's deeper than 1 cm under the skin and 2-5 cm wide.

Exclusion Criteria

I have had or will have a procedure to heat and destroy my tumor.

I have had laser or radiation therapy on the breast being targeted.

You have breast implants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Ablation

Eligible and consenting patients will be imaged using HMI, undergo HMIgFUS ablation, and then imaged again using HMI

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with results validated by pathological findings

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Harmonic motion imaging guided focused ultrasound (HMIgFUS)

Trial Overview The study tests Harmonic Motion Imaging (HMI) as a guide and monitor for Focused Ultrasound Surgery (FUS) in treating benign and stage I non-metastatic breast cancers. It aims to see if HMI can help track the success of ultrasound treatments.

How Is the Trial Designed?

Group I: HMIgFUS Experimental Treatment 1 Intervention

Each study participants' tumors will be imaged using Harmonic Motion Imaging (HMI), an ultrasound elastography method. A central portion of the tumor will then be ablated and monitored using Harmonic Motion Imaging guided Focus Ultrasound (HMIgFUS). Only one portion of the tumor will be ablated; the other portions of the tumor, including tumor margins, will not be ablated. Following ablation, the tumor will be imaged again using HMI.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Focused ultrasound surgery (FUS) is a noninvasive treatment option that uses imaging guidance to target cancer, offering a promising alternative to traditional surgical methods.

FUS has the potential to enhance cancer therapy and improve the delivery of drugs directly to tumors, which could lead to more effective treatments with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused ultrasound surgery in oncology: overview and principles. Tempany, CM., McDannold, NJ., Hynynen, K., et al.[2022]

Focused ultrasound surgery (FUS) is a noninvasive treatment that effectively destroys targeted tissues while protecting surrounding areas, making it a safe option for patients.

When combined with magnetic resonance guidance (MRgFUS), this technique allows for real-time monitoring and personalized treatment, showing promising results in conditions like uterine fibroids and potential applications in prostate and liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ExAblate magnetic resonance-guided focused ultrasound system in multiple body applications. Dick, EA., Gedroyc, WM.[2010]

Harmonic motion imaging (HMI) using a steered focused ultrasound (FUS) beam allows for efficient imaging of tissue stiffness without moving the transducer, enhancing the imaging process.

The study demonstrated that HMI can effectively image tissue displacements within a range of ±1.7 mm laterally and ±2 mm axially, indicating its potential for broader applications in monitoring high-intensity focused ultrasound treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Ultrasound Steering for Harmonic Motion Imaging. Han, Y., Payen, T., Wang, S., et al.[2019]

Harmonic Motion Imaging (HMI) is a promising non-invasive technique that uses focused ultrasound to detect tumors by measuring tissue stiffness, which can differentiate tumors from surrounding normal tissue.

HMI can be integrated with thermal treatments like high-intensity focused ultrasound (HIFU), enhancing both tumor detection and treatment monitoring without the use of ionizing radiation, making it a safe and cost-effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmonic Motion Imaging (HMI) for Tumor Imaging and Treatment Monitoring. Konofagou, EE., Maleke, C., Vappou, J.[2020]

The new Harmonic Motion Imaging (HMI) system significantly improves the speed of data acquisition by 4.5-5.2 times compared to traditional methods, allowing for more efficient monitoring of tissue properties during high-intensity focused ultrasound (HIFU) treatments.

Preliminary results in a human subject with a breast tumor showed that the HMI system could effectively differentiate between tumor and surrounding tissue, indicating its potential for clinical applications in breast cancer imaging and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Efficient and Multi-Focal Focused Ultrasound Technique for Harmonic Motion Imaging. Saharkhiz, N., Kamimura, HAS., Konofagou, EE.[2023]

The new harmonic motion imaging (HMI) technique allows for real-time monitoring of tissue displacement and stiffness using a single focused ultrasound transducer, which simplifies the process compared to previous methods that required two transducers.

This technique demonstrated the ability to monitor high-intensity focused ultrasound (HIFU) treatments effectively, providing a low-cost and localized approach to assess tissue response during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-element focused ultrasound transducer method for harmonic motion imaging. Maleke, C., Pernot, M., Konofagou, EE.[2017]

Magnetic resonance guided focused ultrasound surgery (MRgFUS) is an effective non-invasive treatment for relieving metastatic bone pain, as confirmed by a consensus of international experts.

The review outlines key areas for advancing the use of FUS in oncology, including treatment goals, indications, technical aspects, and future research priorities, aiming to enhance its acceptance and application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International consensus on use of focused ultrasound for painful bone metastases: Current status and future directions. Huisman, M., ter Haar, G., Napoli, A., et al.[2022]

Harmonic motion imaging (HMI) has been developed as a real-time monitoring tool for high-intensity focused ultrasound (HIFU) treatment, showing significant differences in tissue stiffness between normal and cancerous breast tissues in a study of 36 specimens.

The technique effectively monitored changes in tissue stiffness before and after HIFU ablation, demonstrating a 53.84% decrease in normal tissue and a 44.69% decrease in invasive ductal carcinoma, indicating its potential as a clinical tool for breast cancer treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). Han, Y., Wang, S., Hibshoosh, H., et al.[2023]

The Harmonic Motion Imaging for Focused Ultrasound (HMIFU) technique effectively monitors changes in tissue stiffness during thermal therapy in a breast cancer mouse model, demonstrating significant reductions in displacement amplitude before and after lesion formation.

This study indicates that HMIFU can provide real-time feedback on tissue properties during treatment, potentially making thermal ablation procedures more efficient and reliable, while also confirming cell death through histological analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo feasibility of real-time monitoring of focused ultrasound surgery (FUS) using harmonic motion imaging (HMI). Maleke, C., Konofagou, EE.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10697091/

Harmonic Motion Imaging guided Focused Ultrasound ... In this study, three methods were compared for FUS interference filtering during HMI guided FUS ablation (HMIgFUS).

2. 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 ...

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

Harmonic motion imaging of human breast masses Results revealed that both benign and malignant masses were stiffer than the surrounding tissues. However, malignant tumors underwent lower mean ...

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

Development and optimization of a clinical harmonic motion ... Incorporating intraoperative imaging techniques could enable higher rates of clear margins with breast conserving procedures. Such monitoring ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562923003137

Harmonic Motion Imaging-Guided Focused Ultrasound ... In this study, we explored three methods (interleaved, notch filter and FUS-net) of FUS interference filtering from HMIgFUS RF data.

6. 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 ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-12554

Harmonic Motion Imaging-Guided Focused Ultrasound ... This clinical trial assess how harmonic motion imaging guided focused ultrasound surgery can be used in the clinic in treating women with breast tumors.

8. researchgate.net researchgate.net/publication/396722051_An_Integrated_Harmonic_Motion_Imaging-Guided_Focused_Ultrasound_System_HMIgFUS_for_Breast_Cancer_Ablation_and_Monitoring_in_the_Clinic

An Integrated Harmonic Motion Imaging-Guided Focused ... The successful clinical application of high intensity focused ultrasound (HIFU) ablation depends on reliable monitoring of the lesion formation.