36 Participants Needed

HMI-guided Focused Ultrasound for Breast Cancer

EK
XJ
Overseen ByXiaoyue J Li, MSc
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12367

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.13689

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

EK

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.
See 1 more

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
1Treatment groups
Experimental Treatment
Group I: HMIgFUSExperimental Treatment1 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.

Find a Clinic Near You

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

References

Focused Ultrasound Steering for Harmonic Motion Imaging. [2019]
Focused ultrasound surgery in oncology: overview and principles. [2022]
An Efficient and Multi-Focal Focused Ultrasound Technique for Harmonic Motion Imaging. [2023]
International consensus on use of focused ultrasound for painful bone metastases: Current status and future directions. [2022]
In vivo feasibility of real-time monitoring of focused ultrasound surgery (FUS) using harmonic motion imaging (HMI). [2016]
Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). [2023]
ExAblate magnetic resonance-guided focused ultrasound system in multiple body applications. [2010]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Harmonic Motion Imaging (HMI) for Tumor Imaging and Treatment Monitoring. [2020]
Single-element focused ultrasound transducer method for harmonic motion imaging. [2017]
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