Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
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| ClinicalTrials.gov Identifier: NCT05219695 |
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Recruitment Status :
Recruiting
First Posted : February 2, 2022
Last Update Posted : February 8, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibroadenoma Breast Cancer Stage I | Procedure: Harmonic motion imaging guided focused ultrasound (HMIgFUS) | Not Applicable |
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 less invasive than the current surgical or invasive ablative intervention may be more beneficial. FUS is a noninvasive, non-ionizing treatment procedure that precisely focuses and delivers a large amount of ultrasound energy to the target area, causing localized temperature rise and cell necrosis at the target. The main advantage of focused ultrasound ablation (FUS) is that it avoids surgery. Without surgery, recovery from the procedure is much faster, patients may experience less pain, and cosmetological results may be improved.
The efficacy and safety of FUS rely heavily on treatment monitoring. Treatment imaging techniques currently used include MRI and ultrasound Bmode imaging. Magnetic resonance imaging (MRI) thermometry is used to detect the temperature rise across the FUS treatment area. However, MRI guidance can be expensive and time-consuming compared to ultrasound-based HIFU guidance methods. Conventional B-mode based 'hyperecho' tracking can be challenging for HIFU monitoring, as it is sensitive to cavitation, which occurs at high temperatures.
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. The investigators have shown in pre-clinical data that HMI has the ability to monitor mechanical changes in tissue that occur with ablation. The combination of FUS with HMI monitoring is termed HMI guided FUS, or HMIgFUS.
This study aims to evaluate the HMI technique for monitoring FUS ablation in a clinical setting. Eligible and consenting patients will be imaged using HMI, and then will undergo HMIgFUS at a central position inside the tumor. The tumor will be imaged using HMI again following ablation. Following our study, the patients will undergo their scheduled surgery. The purpose of this study is to evaluate HMIgFUS in a lower risk setting, as the tumor will be excised following our study, to better inform future studies, in which surgery may not be needed.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI) |
| Actual Study Start Date : | January 19, 2022 |
| Estimated Primary Completion Date : | May 2025 |
| Estimated Study Completion Date : | May 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Procedure: 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. |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women age ≥18
- Patients with fibroadenoma (benign tumor) 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 the clinical care team (ideal target lesion upper boundary should be deeper than 1 cm below the skin, and the ideal size of the lesion should be 2-5 cm in diameter)
Exclusion Criteria:
- Pregnant or lactating women
- Patients with breast implants
- Patients with a history of laser or radiation therapy to the targeted breast
- Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219695
| Contact: Elisa Konofagou, PhD | 212-342-0863 | ek2191@columbia.edu | |
| Contact: Xiaoyue J Li, MSc | 435-757-9675 | xjl2102@columbia.edu |
| United States, New York | |
| Columbia University Irving Medical Center/NYP | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Elisa Konofagou, PhD 212-342-0863 ek2191@columbia.edu | |
| Contact: Xiaoyue Li 435-757-9675 xjl2102@columbia.edu | |
| Principal Investigator: Elisa Konofagou, PhD | |
| Principal Investigator: | Elisa Konofagou, PhD | Professor of Biomedical Engineering |
| Responsible Party: | Elisa Konofagou, Professor of Biomedical Engineering, Columbia University |
| ClinicalTrials.gov Identifier: | NCT05219695 |
| Other Study ID Numbers: |
AAAS9859 |
| First Posted: | February 2, 2022 Key Record Dates |
| Last Update Posted: | February 8, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No individual participant data (IPD) will be shared with other researchers. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Breast Neoplasms Fibroadenoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |