Breast CancerNCT04863443
Nonlinear Elasticity Mapping of Breast Masses
An observational study of Breast Cancer, run by Mayo Clinic at 2 sites in United States.
Trial summary
This proposed technique, called "Nonlinear Elasticity Mapping (NEM)", is an innovative approach to estimate (i.e., linear and nonlinear) elasticity to provide complementary and relevant information for identification and characterization of breast masses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 172 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2014to 30 Aug 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female and male patient volunteers, aged 18 years and older, without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound
Who may be able to join
- Without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound.
Who cannot join
- Previous mastectomy or implants
- Any condition that does not allow proper use of imaging devices.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Mayo Clinic
Rochester, Minnesota, 55905
About this study
This proposed technique, called "Nonlinear Elasticity Mapping (NEM)", is an innovative approach to estimate (i.e., linear and nonlinear) elasticity to provide complementary and relevant information for identification and characterization of breast masses.
The proposed technique includes imaging the (nonlinear) elasticity parameter in a quantitative manner and measuring two new and relevant parameters. These parameters, together with linear elasticity, are used to differentiate breast masses. The first parameter is the nonlinearity of the elasticity.
Read the detailed description
Measuring the nonlinearity of elasticity is obtained by recording ultrasound scans of object under different values of externally applied compression, and processing the resulting data. The central element of the proposed method is the solution of an inverse problem by which the linear and nonlinear parameters are estimated and a map of tissue nonlinearity is produced, in which the malignant masses can be identified. In addition to estimating the elasticity, will also evaluate the heterogeneity of the (linear) elasticity parameter distribution within the mass as an indicator of malignancy. In a previously performed pilot study, tested the proposed method on a small group of patients.
The goal of this project is to take the next logical step, which is to test this method in a clinical study on a larger population of patients to obtain statistically meaningful results. Assuming that the proposed method continues to demonstrate high specificity, this technique can have a significant impact on breast cancer diagnosis and management.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound
- Keywords
- Breast, Mass
- Medical subject headings
- Breast Neoplasms, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called Supersonics Aixplorer, Verasonics, Alpinion
ultrasound scanner to collect sonographic imaging data from the breast
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the diagnostic performance of the proposed nonlinear elasticity mapping method by measuring the nonlinear elasticity parameter.
In order to quantify this diagnostic potential we evaluate the average value of the relative shear modulus and the nonlinear parameter within each mass and correlate the results to the pathology results of breast biopsy.
Measured: Up to 2 weeks post breast biopsy
Diagnostic performance of elasticity heterogeneity with measuring the combined linear and nonlinear elasticity parameters
Complement elasticity with additional quantitative information about linear and nonlinear elasticity parameters, that is relevant to the disease mechanism.
Measured: Up to 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 posted28 Apr 2021
- Study start24 Jul 2014
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
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
- Prospective
- Enrolment
- 172 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863443
- Sponsor's protocol ID
- 14-004964
- Other IDs
- R01CA195527
- Status last verified
- Oct 2025
- First submitted
- 22 Apr 2021
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonlinear Elasticity Mapping of Breast Masses
- ClinicalTrials.gov ID
- NCT04863443
- Acronym / sponsor ID
- 14-004964
- Conditions
- Breast Cancer
- Keywords
- Breast, Mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 28 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.
This proposed technique, called "Nonlinear Elasticity Mapping (NEM)", is an innovative approach to estimate (i.e., linear and nonlinear) elasticity to provide complementary and relevant information for identification and characterization of breast masses.
The proposed technique includes imaging the (nonlinear) elasticity parameter in a quantitative manner and measuring two new and relevant parameters. These parameters, together with linear elasticity, are used to differentiate breast masses. The first parameter is the nonlinearity of the elasticity.
Detailed description
Measuring the nonlinearity of elasticity is obtained by recording ultrasound scans of object under different values of externally applied compression, and processing the resulting data. The central element of the proposed method is the solution of an inverse problem by which the linear and nonlinear parameters are estimated and a map of tissue nonlinearity is produced, in which the malignant masses can be identified. In addition to estimating the elasticity, will also evaluate the heterogeneity of the (linear) elasticity parameter distribution within the mass as an indicator of malignancy. In a previously performed pilot study, tested the proposed method on a small group of patients.
The goal of this project is to take the next logical step, which is to test this method in a clinical study on a larger population of patients to obtain statistically meaningful results. Assuming that the proposed method continues to demonstrate high specificity, this technique can have a significant impact on breast cancer diagnosis and management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male patient volunteers, aged 18 years and older, without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound
Key inclusion criteria (1 listed)
- Without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound.
Key exclusion criteria (2 listed)
- Previous mastectomy or implants
- Any condition that does not allow proper use of imaging devices.
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 |
|---|---|---|
| UltrasoundAlso: Supersonics Aixplorer, Verasonics, Alpinionultrasound scanner to collect sonographic imaging data from the breast | Device | – |
Primary outcome
Determine the diagnostic performance of the proposed nonlinear elasticity mapping method by measuring the nonlinear elasticity parameter.
Time frame: Up to 2 weeks post breast biopsy
In order to quantify this diagnostic potential we evaluate the average value of the relative shear modulus and the nonlinear parameter within each mass and correlate the results to the pathology results of breast biopsy.
Diagnostic performance of elasticity heterogeneity with measuring the combined linear and nonlinear elasticity parameters
Time frame: Up to 2 weeks post biopsy
Complement elasticity with additional quantitative information about linear and nonlinear elasticity parameters, that is relevant to the disease mechanism.
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 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 2 sites 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 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 diagnostic performance of the proposed nonlinear elasticity mapping method by measuring the nonlinear elasticity parameter. (time frame: Up to 2 weeks post breast 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 7 Oct 2025.