RightFit
RecruitingPhase 1

Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study will investigate Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) method for ablation and sonoporation monitoring of breast tumors."
  • "The hypothesis behind this proposed study is that High Intensity Focused Ultrasound (HIFU) can be used to ablate tumor tissue, and microbubble-mediated Low Intensity Focused Ultrasound (LIFU) can be used to sonoporate tumor vasculature."
  • "The objectives of this study are to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for guiding and monitoring 1) Focused Ultrasound Surgery (FUS) in patients with benign tumors and stage 1 non-metastatic breast cancers and 2) microbubble-mediated Low Intensity Focused Ultrasound (LIFU), i.e., sonoporation, in early-stage, non-metastatic breast cancer patients."
  • "FUS is a non-invasive, non-ionizing treatment procedure that precisely focuses and delivers a large amount of ultrasound energy to the target area, causing a localized temperature rise and cell necrosis at the target."
  • "On the other hand, microbubbles have been approved for use by the FDA in contrast-enhanced ultrasound imaging, e.g., cardiac and liver imaging."
  • "HMI is an ultrasound elasticity method that can provide measurements of the locally generated mechanical response and inherent mechanical properties of tissues."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests focused sound waves to destroy breast tumor tissue with heat or, with tiny bubbles, make tumor blood vessels more open. It also tests imaging to guide treatment and track changes in tumor firmness. It is for women age 18 or older with breast tumors, with different rules for each study group.

This study will investigate Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) method for ablation and sonoporation monitoring of breast tumors. The aim of this study is to evaluate the efficacy of real-time guidance/monitoring and ablation/sonoporation method. The hypothesis behind this proposed study is that High Intensity Focused Ultrasound (HIFU) can be used to ablate tumor tissue, and microbubble-mediated Low Intensity Focused Ultrasound (LIFU) can be used to sonoporate tumor vasculature. The investigators of this study also hypothesize that HMI can be used to monitor HIFU ablation by measuring the changes in tissue stiffness that occur as a result of thermal ablation, guide LIFU sonoporation and HIFU ablation targeting stiff tumor tissue, and the HMI-monitored stiffness changes during ablation will correlate with post-treatment immune response. The ultimate goals of this study are: first, to assess whether these techniques can be used in the clinic in order to provide a well-monitored, noninvasive tumor ablation/sonoporation method for benign tumors and breast cancers, to minimize side effects due to invasiveness and enhance therapeutic effects of current methods; second, to make full use of the real-time monitoring capability of HMIgFUS for more precise, point-of-care treatment planning to ensure success of ablation/sonoporation and immune activation.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Women age 18 or older.
  • Heat treatment group: A noncancerous breast tumor or stage I breast cancer that has not spread, including to lymph nodes in the armpit.
  • Heat treatment group: Scheduled for surgery to remove the tumor.
  • Tiny-bubble group: Breast cancer that has grown into nearby tissue, at any stage, with the main breast tumor at least 4 mm wide.
  • Tiny-bubble group: A doctor says you can receive medicine that treats cancer throughout the body before surgery, at a dose and schedule the doctor approves.

Who can't join

  • Both groups: Pregnant or breastfeeding.
  • Both groups: Breast implants.
  • Both groups: Past laser or radiation treatment to the breast being treated.
  • Heat treatment group: Have received or are scheduled to receive heat treatment or other treatment of the tumor as part of regular care.
  • Tiny-bubble group: A medical reason you cannot receive ultrasound contrast agents, which help make images clearer, or an allergy to them. This includes Definity or polyethylene glycol (PEG) allergy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Focused Ultrasound Surgery Inclusion criteria: * Women age 18 years or older with benign tumors or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes) * Scheduled to receive surgical resection of the tumor by their clinical care team Exclusion criteria: * Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor as part of their clinical care * Pregnant or lactating * Presence of breast implants * Have a history of laser or radiation therapy to the targeted breast. Microbubble-mediated LIFU, i.e., sonoporation Inclusion criteria: * Women 18 years or older * Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician * Any stage invasive breast cancer provided the primary breast tumor size is at least 4 mm Exclusion criteria: * Pregnant or lactating * Presence of breast implants * History of laser or radiation therapy to the affected breast * Contraindication history or hypersensitivity to ultrasound contrast agents, e.g., Definity, including polyethylene glycol (PEG) allergy.

Study sites (1)

NY