Harmonic Motion Imaging for Early-Stage Breast Cancer
Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Recruiting
Phase 1Interventional Study
FibroadenomaBreast Cancer Stage I
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
82 (estimated)
Sponsor
Columbia University · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer or benign tumors. Participants will help test a new imaging technique during surgery to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman age 18 or older.
I have been diagnosed with fibroadenoma or early-stage non-metastatic breast cancer.
I am scheduled for surgical removal of my tumor.
My tumor is at least 1 cm below the skin.
My tumor size is between 2 and 5 cm in diameter.
You may not be able to join if
I am pregnant or breastfeeding.
I have breast implants.
I have had laser or radiation therapy on the targeted breast.
I have received or am scheduled for thermal treatment of my tumor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, an…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 crite…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.