Breast CancerSAVENCT04841252
Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FDA approved GE LOGIQ E9 (LE9) ultrasound and Alpinion clinical ultrasound machine
- Type of treatment
- Medical device
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2012to 25 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- FDA approved GE LOGIQ E9 (LE9) ultrasound, Alpinion clinical ultrasound machine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDA approved GE LOGIQ E9 (LE9) ultrasoundDevice
Ultrasound
Alpinion clinical ultrasound machineDevice
Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Before biopsy or at least 2 weeks post biopsy
Determine the efficacy of SAVE method in classifying non-specific masses in a group of breast patients on the follow-up list.
The threshold determined in Aim 1 will be applied to the patients in this sample to calculate the diagnostic performance
Measured: Before biopsy or at least 2 weeks post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start19 Dec 2012
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Azra Alizad, Mayo Clinic
- Investigators
- Azra Alizad, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841252
- Sponsor's protocol ID
- 12-009399
- Other IDs
- R01CA168575
- Acronym
- SAVE
- Status last verified
- Mar 2026
- First submitted
- 6 Apr 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method
- ClinicalTrials.gov ID
- NCT04841252
- Acronym / sponsor ID
- SAVE / 12-009399
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Dec 2012 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDA approved GE LOGIQ E9 (LE9) ultrasoundUltrasound | Device | – |
| Alpinion clinical ultrasound machineUltrasound | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Alizad, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.