Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05219695
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2022-01-21
Brief Title:
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging HMI
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging HMI
Status:
RECRUITING
Status Verified Date:
2024-05
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?:
None