Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT05219695
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: