HMI-guided Focused Ultrasound for Breast Cancer
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Ablation
Eligible and consenting patients will be imaged using HMI, undergo HMIgFUS ablation, and then imaged again using HMI
Follow-up
Participants are monitored for safety and effectiveness after treatment, with results validated by pathological findings
Treatment Details
Interventions
- Harmonic motion imaging guided focused ultrasound (HMIgFUS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor