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

Trial Summary

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 data supports the effectiveness of the treatment Harmonic motion imaging guided focused ultrasound (HMIgFUS) for breast cancer?

Research shows that Harmonic Motion Imaging (HMI) can effectively monitor and guide focused ultrasound treatments, improving imaging and treatment efficiency. In a study, HMI was used to successfully image and treat breast tumors in a human subject, indicating its potential effectiveness for breast cancer treatment. ^{1 2 3 4 5}

Is HMI-guided Focused Ultrasound generally safe for humans?

Focused ultrasound surgery (FUS) is a noninvasive treatment that has been used safely in various conditions, including uterine fibroids and bone metastases, with minimal pain and the ability to spare surrounding tissues. The combination of magnetic resonance guidance with FUS (MRgFUS) enhances safety by allowing real-time treatment monitoring. While specific safety data for HMI-guided FUS in breast cancer is limited, the general safety profile of FUS in other applications is promising. ^{1 2 3 6 7}

How is the HMI-guided Focused Ultrasound treatment for breast cancer different from other treatments?

HMI-guided Focused Ultrasound (HMIgFUS) is unique because it uses sound waves to create a non-contact 'internal palpation' to assess tissue stiffness and guide treatment, allowing for precise targeting and monitoring of tumors without surgery or radiation. This method is non-invasive, cost-effective, and can provide real-time imaging and treatment monitoring, making it a novel approach compared to traditional surgical or radiation therapies. ^{1 3 6 8 9}

What is the purpose of this trial?

The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.

Research Team

Elisa Konofagou, PhD

Principal Investigator

Professor of Biomedical Engineering

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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) 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) 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]

References

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

Focused Ultrasound Steering for Harmonic Motion Imaging. [2019]

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

Focused ultrasound surgery in oncology: overview and principles. [2022]

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

An Efficient and Multi-Focal Focused Ultrasound Technique for Harmonic Motion Imaging. [2023]

4. England pubmed.ncbi.nlm.nih.gov

International consensus on use of focused ultrasound for painful bone metastases: Current status and future directions. [2022]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). [2023]

7. England pubmed.ncbi.nlm.nih.gov

ExAblate magnetic resonance-guided focused ultrasound system in multiple body applications. [2010]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Harmonic Motion Imaging (HMI) for Tumor Imaging and Treatment Monitoring. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Single-element focused ultrasound transducer method for harmonic motion imaging. [2017]