FibroadenomaPhase 1NCT05219695
Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
A Phase 1 study testing Harmonic motion imaging guided focused ultrasound (HMIgFUS), Microbubble-mediated Low Intensity Focused Ultrasound (LIFU) and Microbubbles in people with Fibroadenoma and Breast Cancer Stage I, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroadenoma, Breast Cancer Stage I
- What is being tested?
- Harmonic motion imaging guided focused ultrasound (HMIgFUS), Microbubble-mediated Low Intensity Focused Ultrasound (LIFU) and Microbubbles
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to May 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Pregnant or lactating
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center/NYP
New York, New York, 10032
Shiqi Hu, MSc, 917-664-5382, sh4193@columbia.edu
Bret Taback, MD
About this study
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.
Read the detailed description
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. The secondary objective is to investigate the correlation between HMI-informed treatment response with patients' post-treatment immune profile.
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. Patients with small solid tumors without positive lymph nodes have the highest survival rate. However, especially for patients with benign tumors (most common in younger women) and older patients (>65 years old) who fit these criteria, an alternative treatment technique that is far less invasive than the current surgical or invasive ablative intervention may be more beneficial. The main advantage of treating breast tumors with focused ultrasound ablation (FUS) is its noninvasiveness, i.e., no need for surgery. Without surgery, recovery from the procedure is much faster, patients may experience less pain, and cosmetic results may be improved.
On the other hand, microbubbles have been approved for use by the FDA in contrast-enhanced ultrasound imaging, e.g., cardiac and liver imaging. Research has shown that microbubble mediated LIFU can improve intratumoral drug uptake via a phenomenon termed sonoporation, as a result of cavitation of microbubbles. Sonoporation does not cause any unexpected bias or additional toxicity compared with chemotherapy alone. Currently, sonoporation lacks imaging guidance. In this study, HMI and contrast-enhanced power Doppler will be investigated to guide and monitor sonoporation. Microbubbles will be injected at an FDA-approved dose and route.
HMI is an ultrasound elasticity method that can provide measurements of the locally generated mechanical response and inherent mechanical properties of tissues. The result is a new image that contains unique localized information on the relative stiffness in and around the tumor. HMI can be performed simultaneously with HIFU ablation so that HIFU ablation can be monitored with HMI without interruption of HIFU treatment. When used for monitoring thermal ablation using FUS, the integrated system is referred to as HMIgFUS, which stands for Harmonic Motion Imaging for Focused Ultrasound. The resulting synchronous monitoring system has the ability to follow and identify the areas of necrosis. This study aims to evaluate the HMI technique for monitoring FUS ablation in a clinical setting and investigate the correlation between HMI-monitored displacement and patients' immune response.
- Conditions
- Fibroadenoma, Breast Cancer Stage I
- Being tested
- Harmonic motion imaging guided focused ultrasound (HMIgFUS), Microbubble-mediated Low Intensity Focused Ultrasound (LIFU), Microbubbles
- Medical subject headings
- Fibroadenoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic motion imaging guided focused ultrasound (HMIgFUS)Procedure or surgery
Harmonic motion imaging guided focused ultrasound (HMIgFUS) is a combined treatment and imaging method, in which focused ultrasound (FUS) is used to thermally ablate tissue and harmonic motion imaging (HMI) is used for FUS guidance and monitoring. FUS applies high intensity focused ultrasound waves at its specified target to heat the tissue over a specified duration, causing cell death at the target area. HMI is an elasticity imaging technique which induces dynamic tissue vibrations at the target for tissue elasticity characterization.
One of the inclusion criteria for this study is that participants must be scheduled for surgical excision of their breast tumor. In this study, HMIgFUS will be applied to anesthetized participants immediately prior to their scheduled surgery. HMI imaging will also be performed immediately prior to and after HMIgFUS application.
Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)Procedure or surgery
Also called Sonoporation
Microbubble-mediated Low Intensity Focused Ultrasound (LIFU) is a minimally invasive procedure which delivers localized ultrasound energy to the target region, causing cavitation of microbubbles to safely and transiently increase the permeability of vessels that aids local delivery of medicine.
MicrobubblesDrug
Also called DEFINITY, Perflutren Lipid Microsphere
Definity is a diagnostic ultrasound enhancing agent used to improve the clarity of echocardiograms and other ultrasound images. It consists of tiny, gas-filled lipid microspheres (about the size of a red blood cell) that circulate in the bloodstream to reflect ultrasound waves.
| Study group | Role | What they receive |
|---|---|---|
| HMIgFUS | Experimental | 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. Receives: Procedure: Harmonic motion imaging guided focused ultrasound (HMIgFUS) |
| HMIgLIFU | Experimental | Eligible participants have early-stage breast cancers and are scheduled to receive neoadjuvant chemotherapy as part of their clinical care. On the day of chemotherapy infusion, elasticity images of the lesions and surrounding tissues will be collected using HMI before infusion after tumor identification on ultrasound imaging. Within an hour after infusion, the participants' tumors will be treated with microbubble-mediated Low-Intensity Focused Ultrasound (LIFU), i.e. sonoporation. Receives: Procedure: Microbubble-mediated Low Intensity Focused Ultrasound (LIFU); Drug: Microbubbles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with ablation
To identify markers of ablation progression using HMIgFUS images, thereby predicting whether ablation occurred or not. The investigators will also use differences in HMI imaging performed before and after ablation to assess the presence of ablation. The results from both of these methods will be validated with pathological findings, to determine whether ablation was achieved.
Measured: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
R2 value of ablated lesion depth
The depth of the lesion (in mm away from the surface of the skin) as shown on HMIgFUS images will be compared and validated with pathological findings.
Measured: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
R2 value of ablated lesion width
The width of the lesion (in mm laterally across the lesion) as shown on HMIgFUS images will be compared and validated with pathological findings.
Measured: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
R2 value of ablated lesion area
The area of the lesion (in mm^2) as shown on HMIgFUS images will be compared and validated with pathological findings.
Measured: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start19 Jan 2022
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibroadenomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bret Taback, Columbia University
- Investigators
- Bret Taback, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219695
- Sponsor's protocol ID
- AAAS9859
- Other IDs
- 5R01CA228275, 1R01CA301199-01A1
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared with other researchers.
Publications
Han Y, Wang S, Payen T, Konofagou E. Fast lesion mapping during HIFU treatment using harmonic motion imaging guided focused ultrasound (HMIgFUS) in vitro and in vivo. Phys Med Biol. 2017 Apr 21;62(8):3111-3123. doi: 10.1088/1361-6560/aa6024. Epub 2017 Mar 21.
PubMed 28323638Han Y, Wang S, Hibshoosh H, Taback B, Konofagou E. Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). Breast Cancer Res. 2016 May 9;18(1):46. doi: 10.1186/s13058-016-0707-3.
PubMed 27160778Hernot S, Klibanov AL. Microbubbles in ultrasound-triggered drug and gene delivery. Adv Drug Deliv Rev. 2008 Jun 30;60(10):1153-66. doi: 10.1016/j.addr.2008.03.005. Epub 2008 Apr 3.
PubMed 18486268Pitt WG, Husseini GA, Staples BJ. Ultrasonic drug delivery--a general review. Expert Opin Drug Deliv. 2004 Nov;1(1):37-56. doi: 10.1517/17425247.1.1.37.
PubMed 16296719
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
- ClinicalTrials.gov ID
- NCT05219695
- Acronym / sponsor ID
- AAAS9859
- Conditions
- Fibroadenoma, Breast Cancer Stage I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The secondary objective is to investigate the correlation between HMI-informed treatment response with patients' post-treatment immune profile.
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. Patients with small solid tumors without positive lymph nodes have the highest survival rate. However, especially for patients with benign tumors (most common in younger women) and older patients (>65 years old) who fit these criteria, an alternative treatment technique that is far less invasive than the current surgical or invasive ablative intervention may be more beneficial. The main advantage of treating breast tumors with focused ultrasound ablation (FUS) is its noninvasiveness, i.e., no need for surgery. Without surgery, recovery from the procedure is much faster, patients may experience less pain, and cosmetic results may be improved.
On the other hand, microbubbles have been approved for use by the FDA in contrast-enhanced ultrasound imaging, e.g., cardiac and liver imaging. Research has shown that microbubble mediated LIFU can improve intratumoral drug uptake via a phenomenon termed sonoporation, as a result of cavitation of microbubbles. Sonoporation does not cause any unexpected bias or additional toxicity compared with chemotherapy alone. Currently, sonoporation lacks imaging guidance. In this study, HMI and contrast-enhanced power Doppler will be investigated to guide and monitor sonoporation. Microbubbles will be injected at an FDA-approved dose and route.
HMI is an ultrasound elasticity method that can provide measurements of the locally generated mechanical response and inherent mechanical properties of tissues. The result is a new image that contains unique localized information on the relative stiffness in and around the tumor. HMI can be performed simultaneously with HIFU ablation so that HIFU ablation can be monitored with HMI without interruption of HIFU treatment. When used for monitoring thermal ablation using FUS, the integrated system is referred to as HMIgFUS, which stands for Harmonic Motion Imaging for Focused Ultrasound. The resulting synchronous monitoring system has the ability to follow and identify the areas of necrosis. This study aims to evaluate the HMI technique for monitoring FUS ablation in a clinical setting and investigate the correlation between HMI-monitored displacement and patients' immune response.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMIgFUS | Experimental | Procedure: Harmonic motion imaging guided focused ultrasound (HMIgFUS)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. |
| HMIgLIFU | Experimental | Procedure: Microbubble-mediated Low Intensity Focused Ultrasound (LIFU), Drug: MicrobubblesEligible participants have early-stage breast cancers and are scheduled to receive neoadjuvant chemotherapy as part of their clinical care. On the day of chemotherapy infusion, elasticity images of the lesions and surrounding tissues will be collected using HMI before infusion after tumor identification on ultrasound imaging. Within an hour after infusion, the participants' tumors will be treated with microbubble-mediated Low-Intensity Focused Ultrasound (LIFU), i.e. sonoporation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonic motion imaging guided focused ultrasound (HMIgFUS)Harmonic motion imaging guided focused ultrasound (HMIgFUS) is a combined treatment and imaging method, in which focused ultrasound (FUS) is used to thermally ablate tissue and harmonic motion imaging (HMI) is used for FUS guidance and monitoring. FUS applies high intensity focused ultrasound waves at its specified target to heat the tissue over a specified duration, causing cell death at the target area. HMI is an elasticity imaging technique which induces dynamic tissue vibrations at the target for tissue elasticity characterization. One of the inclusion criteria for this study is that participants must be scheduled for surgical excision of their breast tumor. In this study, HMIgFUS will be applied to anesthetized participants immediately prior to their scheduled surgery. HMI imaging will also be performed immediately prior to and after HMIgFUS application. | Procedure or surgery | HMIgFUS |
| Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)Also: SonoporationMicrobubble-mediated Low Intensity Focused Ultrasound (LIFU) is a minimally invasive procedure which delivers localized ultrasound energy to the target region, causing cavitation of microbubbles to safely and transiently increase the permeability of vessels that aids local delivery of medicine. | Procedure or surgery | HMIgLIFU |
| MicrobubblesAlso: DEFINITY, Perflutren Lipid MicrosphereDefinity is a diagnostic ultrasound enhancing agent used to improve the clarity of echocardiograms and other ultrasound images. It consists of tiny, gas-filled lipid microspheres (about the size of a red blood cell) that circulate in the bloodstream to reflect ultrasound waves. | Drug | HMIgLIFU |
Primary outcome
Number of patients with ablation
Time frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
To identify markers of ablation progression using HMIgFUS images, thereby predicting whether ablation occurred or not. The investigators will also use differences in HMI imaging performed before and after ablation to assess the presence of ablation. The results from both of these methods will be validated with pathological findings, to determine whether ablation was achieved.
R2 value of ablated lesion depth
Time frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
The depth of the lesion (in mm away from the surface of the skin) as shown on HMIgFUS images will be compared and validated with pathological findings.
R2 value of ablated lesion width
Time frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
The width of the lesion (in mm laterally across the lesion) as shown on HMIgFUS images will be compared and validated with pathological findings.
R2 value of ablated lesion area
Time frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
The area of the lesion (in mm^2) as shown on HMIgFUS images will be compared and validated with pathological findings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 28323638Han Y, Wang S, Payen T, Konofagou E. Fast lesion mapping during HIFU treatment using harmonic motion imaging guided focused ultrasound (HMIgFUS) in vitro and in vivo. Phys Med Biol. 2017 Apr 21;62(8):3111-3123. doi: 10.1088/1361-6560/aa6024. Epub 2017 Mar 21.
- Background: PubMed 27160778Han Y, Wang S, Hibshoosh H, Taback B, Konofagou E. Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). Breast Cancer Res. 2016 May 9;18(1):46. doi: 10.1186/s13058-016-0707-3.
- Background: PubMed 18486268Hernot S, Klibanov AL. Microbubbles in ultrasound-triggered drug and gene delivery. Adv Drug Deliv Rev. 2008 Jun 30;60(10):1153-66. doi: 10.1016/j.addr.2008.03.005. Epub 2008 Apr 3.
- Background: PubMed 16296719Pitt WG, Husseini GA, Staples BJ. Ultrasonic drug delivery--a general review. Expert Opin Drug Deliv. 2004 Nov;1(1):37-56. doi: 10.1517/17425247.1.1.37.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bret Taback, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Harmonic motion imaging guided focused ultrasound (HMIgFUS), Microbubble-mediated Low Intensity Focused Ultrasound (LIFU) and Microbubbles in people with Fibroadenoma and Breast Cancer Stage I, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiqi Hu, MSc (917-664-5382, sh4193@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with ablation (time frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219695, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.