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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
Sponsor:
Information provided by (Responsible Party):
Azra Alizad, Mayo Clinic

Brief Summary:
The purpose of this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The main objective of this proposal is to test the SAVE (Sub-Hertz Analysis of Visco-Elasticity) method on a patient population of sufficient size to determine the sensitivity and specificity for malignant-benign discrimination of breast masses.

Condition or disease Intervention/treatment
Breast Cancer Device: FDA approved GE LOGIQ E9 (LE9) ultrasound Device: Alpinion clinical ultrasound machine

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: FDA approved GE LOGIQ E9 (LE9) ultrasound
    Ultrasound
  • Device: Alpinion clinical ultrasound machine
    Ultrasound


Primary Outcome Measures :
  1. 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.


  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation.
Sampling Method:   Probability Sample
Study Population
Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer
Criteria

Inclusion Criteria:

  • Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation.

Exclusion Criteria:

  • No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices.
  • Only include patients with masses detectable under ultrasound.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Azra Alizad, M.D.         
Sponsors and Collaborators
Mayo Clinic
Additional Information:
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Responsible Party: Azra Alizad, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04841252    
Other Study ID Numbers: 12-009399
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes