Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method (SAVE)
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|ClinicalTrials.gov Identifier: NCT04841252|
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: FDA approved GE LOGIQ E9 (LE9) ultrasound Device: Alpinion clinical ultrasound machine|
Subject will sit or lie back on an examination bed. The investigators will use an ultrasound scanner to collect sonographic imaging data from the breast. For this purpose the investigators may use a clinical scanner such as Supersonics Aixplorer or similar or a research ultrasound machine such as Verasonics (this machine has been use in other Mayo IRB approved protocols such as IRB 11-001953). The ultrasound probe will be placed on the breast to visualize the mass. The probe will be pressed with a constant force for a period of 10-40 seconds. During this time ultrasound data will be recorded by the ultrasound scanner.
To keep the probe pressed on the breast with a constant force, the user may hold the probe by hand and press it steadily against the breast at constant force. This force is only a few Newtons (approximately half a Kg weight) which should be quite tolerable for a typical patient. Alternatively, the investigators may use an automated "actuator" to hold the probe steady and press it against the breast at a constant force to the same level. The reason for pressing the breast is to determine how the breast tissue gradually deforms; therefore this method to some extent simulates breast palpation.
The time needed to scan a subject for this study is short (a few minutes to set up, and about 10-40 seconds to scan). It will take approximately 20 minutes to complete the study. The scan can be done at the time of clinical breast sonography. The subject may be asked to hold her breath during the scan time if possible.
The investigators call this method "Sub-Hertz Analysis of Visco-Elasticity (SAVE)".
To facilitate subject access and shorten patient participation time, the investigator may station our system in the Breast Imaging area where routine clinical imaging procedures are performed.
The investigators may also use the FDA approved GE LOGIQ E9 (LE9) ultrasound system to quantify and image the stiffness of the breast lesion and compare the results to those obtained by the investigational device.
The investigators may also use the Alpinion clinical ultrasound machine, both FDA approved clinical format ECUBE 12 and non FDA approved ECUBE 12R format to acquire ultrasound images.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method|
|Actual Study Start Date :||December 19, 2012|
|Estimated Primary Completion Date :||December 15, 2022|
|Estimated Study Completion Date :||December 15, 2023|
- Device: FDA approved GE LOGIQ E9 (LE9) ultrasound
- Device: Alpinion clinical ultrasound machine
- Determine the efficacy of the SAVE method by correlating its results with pathology in a pathology in a population of patients with suspicious breast masses. [ Time Frame: Before biopsy or at least 2 weeks post biopsy ]
Assessed using a two-phase design. The first phase will be the development aspects to determine a candidate threshold for T1 that produces Optimal diagnostic accuracy as quantified by the largest diagnostic odds ratio.
The second phase of the study will be to apply this candidate threshold to the validation sample enrolled as a part of the specific aim to ensure diagnostic utility. For both phases of the analysis, overall diagnostic accuracy will be quantified by the area under the receiver operating characteristics (ROC) curve.
- Determine the efficacy of SAVE method in classifying non-specific masses in a group of breast patients on the follow-up list. [ Time Frame: Before biopsy or at least 2 weeks post biopsy ]The threshold determined in Aim 1 will be applied to the patients in this sample to calculate the diagnostic performance
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): NCT04841252
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015 firstname.lastname@example.org|
|Principal Investigator: Azra Alizad, M.D.|