Breast CancerNCT06547034
VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker: Evaluation of Compression in Control Subjects
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for elasticity, viscosity, and anisotropy. To this end, we will investigate the effect of applied compression during imaging on elasticity, viscosity, and anisotropy measurements. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 28 Feb 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 30 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two cohorts of patients with negative mammograms and no history of breast disease will be recruited. Both cohorts will have ten women each. The first cohort will be women ages 30-45, and the second cohort will be women ages 46-90.
Who may be able to join
- Patients are 30-90 years of age
- Patients have received a negative result from mammogram screening in past year
- Patients have no history of breast disease
- Informed consent obtained and signed
Who cannot join
- Inability to provide informed consent
- Inability to communicate in English
- Inability to remain motionless for 15 minutes
- Any pathologies of the breast or history of breast disease
- Patients who are pregnant
- Patients who are lactating
- Patients with breast implants
- Patients with implanted cardioverters or pacemakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Surface Compression in Control Subjects
Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for elasticity, viscosity, and anisotropy. To this end, we will investigate the effect of applied compression during imaging on elasticity, viscosity, and anisotropy measurements.
Participants: Twenty women with negative mammograms and no history of breast disease will be recruited. The subjects will be split into two cohorts of ten each, the first cohort aged 30-45 and the second cohort aged 46-90. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals.
Procedures (methods): In this exploratory clinical study, the investigators will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound measurements of elasticity, viscosity, and anisotropy in healthy breast tissue vary based on applied pre-compression. This unblinded, open-label study will be conducted in 20 women with negative mammogram results and no history of breast disease.
Read the detailed description
The primary objective of breast cancer screening is to identify early stage cancer, or precancerous lesions, at a time before symptoms emerge and when treatment is likely to result in a cure. Screening is beneficial when it averts progression of disease to metastasis and/or death, but adverse effects to patients (and unnecessary medical expense) may result downstream from false positives and indiscrimination of masses that will not respond to treatment. The sensitivity of digital mammography, the current screening standard in the US, has been reported in the range of 0.40 to 0.85, with a positive predictive value of 0.31. Sensitivity is increased by augmenting mammography with MRI and B-Mode ultrasound, but false positive rates may also increase. There exists a vital need for a screening technology that exhibits high sensitivity and specificity for cancer detection with early identification of unresponsive masses.
This urgent need could be met by exploiting new imaging biomarkers. Specifically, the mechanical properties of breast tissue have been used for cancer detection, with both elasticity and viscosity demonstrated for discriminating malignant from benign lesions. Further, tissue anisotropy has been shown to correlate with core biopsy result and tumor grade, with large cancers significantly more anisotropic than small cancers. Importantly, while both MRI and ultrasound can be used to measure these biomarkers, ultrasound's cost effectiveness and ease of implementation render it an efficient platform to pursue.
The long-term goal of this research program is to develop a new ultrasound-based breast-screening tool to augment mammography. As a critical first step toward achieving this goal, the primary objective of the proposed research is to evaluate in vivo the replicability of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. These biomarkers will be measured using novel, noninvasive ultrasound technologies under development in Dr. Gallippi's laboratory: 1) Acoustic Radiation Force Impulse (ARFI) ultrasound for interrogating tissue stiffness, 2) Viscoelastic Response (VisR) ultrasound for assessing tissue elasticity and viscosity, and 3) Dynamic Displacement Anisotropy Imaging (DDAI) for measuring tissue anisotropy. These technologies have been demonstrated previously for delineating atherosclerosis, muscular dystrophy, and renal dysfunction.
The investigators hypothesize that ultrasound-derived stiffness, elasticity, viscosity, and anisotropy measurements will vary based on applied compression from the sonographer. This is because applying compression to tissue alters its organization, typically reflected by increased stiffness and viscosity and changes in mechanical anisotropy. To test this hypothesis, they will pursue the following specific aim:
Aim #1: Quantify the change in ultrasound-derived stiffness, elasticity, viscosity, and anisotropy measurements from applied pre-compression. ARFI, VisR, and DDAI imaging will be performed on breast stromal tissue in 20 women with negative mammograms and no history of breast disease. Changes in the ultrasound-derived metrics will be evaluated between no applied compression, 10% applied strain, and 25% applied strain. Additionally, magnitude of change in these metrics with applied strain will be compared between two age cohorts (aged 30-45 vs 46-90) and between breast density levels (as rated on BIRADS scale).
- Conditions
- Breast Cancer
- Being tested
- Ultrasound
- Keywords
- Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Breast Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ages 30-45 | Women ages 30-45 who have received a mammogram in the past year with negative results and have no history of breast disease. Receives: Device: Ultrasound | |
| Ages 46-90 | Women ages 46-90 who have received a mammogram in the past year with negative results and have no history of breast disease. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARFI PD at 0% Strain
Average ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Measured: Baseline imaging
ARFI PD at 10% Strain
Average ARFI Peak Displacement (PD) value across imaging angles with 10% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Measured: Baseline imaging
ARFI PD at 25% Strain
Average ARFI Peak Displacement (PD) value across imaging angles with 25% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Measured: Baseline imaging
VisR Tau at 0% Strain
Average VisR Tau value across imaging angles with 0% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR Tau at 10% Strain
Average VisR Tau value across imaging angles with 10% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR Tau at 25% Strain
Average VisR Tau value across imaging angles with 25% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RE at 0% Strain
Average VisR RE value across imaging angles with 0% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RE at 10% Strain
Average VisR RE value across imaging angles with 10% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RE at 25% Strain
Average VisR RE value across imaging angles with 25% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RV at 0% Strain
Average VisR RV value across imaging angles with 0% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RV at 10% Strain
Average VisR RV value across imaging angles with 10% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RV at 25% Strain
Average VisR RV value across imaging angles with 25% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
ARFI PD DoA at 0% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Measured: Baseline imaging
ARFI PD DoA at 10% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 10% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Measured: Baseline imaging
ARFI PD DoA at 25% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 25% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Measured: Baseline imaging
VisR RE DoA at 0% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 0% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RE DoA at 10% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 10% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RE DoA at 25% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 25% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
VisR RV DoA at 0% Strain
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RV value across imaging angles with 0% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
Measured: Baseline imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start16 Oct 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Caterina Gallippi, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547034
- Sponsor's protocol ID
- LCCC2411
- Other IDs
- 5R01CA281150-02
- Status last verified
- Mar 2025
- First submitted
- 1 Aug 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Surface Compression in Control Subjects
- ClinicalTrials.gov ID
- NCT06547034
- Acronym / sponsor ID
- LCCC2411
- Conditions
- Breast Cancer
- Keywords
- Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 9 Aug 2024 (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.
Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for elasticity, viscosity, and anisotropy. To this end, we will investigate the effect of applied compression during imaging on elasticity, viscosity, and anisotropy measurements.
Participants: Twenty women with negative mammograms and no history of breast disease will be recruited. The subjects will be split into two cohorts of ten each, the first cohort aged 30-45 and the second cohort aged 46-90. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals.
Procedures (methods): In this exploratory clinical study, the investigators will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound measurements of elasticity, viscosity, and anisotropy in healthy breast tissue vary based on applied pre-compression. This unblinded, open-label study will be conducted in 20 women with negative mammogram results and no history of breast disease.
Detailed description
The primary objective of breast cancer screening is to identify early stage cancer, or precancerous lesions, at a time before symptoms emerge and when treatment is likely to result in a cure. Screening is beneficial when it averts progression of disease to metastasis and/or death, but adverse effects to patients (and unnecessary medical expense) may result downstream from false positives and indiscrimination of masses that will not respond to treatment. The sensitivity of digital mammography, the current screening standard in the US, has been reported in the range of 0.40 to 0.85, with a positive predictive value of 0.31. Sensitivity is increased by augmenting mammography with MRI and B-Mode ultrasound, but false positive rates may also increase. There exists a vital need for a screening technology that exhibits high sensitivity and specificity for cancer detection with early identification of unresponsive masses.
This urgent need could be met by exploiting new imaging biomarkers. Specifically, the mechanical properties of breast tissue have been used for cancer detection, with both elasticity and viscosity demonstrated for discriminating malignant from benign lesions. Further, tissue anisotropy has been shown to correlate with core biopsy result and tumor grade, with large cancers significantly more anisotropic than small cancers. Importantly, while both MRI and ultrasound can be used to measure these biomarkers, ultrasound's cost effectiveness and ease of implementation render it an efficient platform to pursue.
The long-term goal of this research program is to develop a new ultrasound-based breast-screening tool to augment mammography. As a critical first step toward achieving this goal, the primary objective of the proposed research is to evaluate in vivo the replicability of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. These biomarkers will be measured using novel, noninvasive ultrasound technologies under development in Dr. Gallippi's laboratory: 1) Acoustic Radiation Force Impulse (ARFI) ultrasound for interrogating tissue stiffness, 2) Viscoelastic Response (VisR) ultrasound for assessing tissue elasticity and viscosity, and 3) Dynamic Displacement Anisotropy Imaging (DDAI) for measuring tissue anisotropy. These technologies have been demonstrated previously for delineating atherosclerosis, muscular dystrophy, and renal dysfunction.
The investigators hypothesize that ultrasound-derived stiffness, elasticity, viscosity, and anisotropy measurements will vary based on applied compression from the sonographer. This is because applying compression to tissue alters its organization, typically reflected by increased stiffness and viscosity and changes in mechanical anisotropy. To test this hypothesis, they will pursue the following specific aim:
Aim #1: Quantify the change in ultrasound-derived stiffness, elasticity, viscosity, and anisotropy measurements from applied pre-compression. ARFI, VisR, and DDAI imaging will be performed on breast stromal tissue in 20 women with negative mammograms and no history of breast disease. Changes in the ultrasound-derived metrics will be evaluated between no applied compression, 10% applied strain, and 25% applied strain. Additionally, magnitude of change in these metrics with applied strain will be compared between two age cohorts (aged 30-45 vs 46-90) and between breast density levels (as rated on BIRADS scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ages 30-45 | – | Device: UltrasoundWomen ages 30-45 who have received a mammogram in the past year with negative results and have no history of breast disease. |
| Ages 46-90 | – | Device: UltrasoundWomen ages 46-90 who have received a mammogram in the past year with negative results and have no history of breast disease. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts of patients with negative mammograms and no history of breast disease will be recruited. Both cohorts will have ten women each. The first cohort will be women ages 30-45, and the second cohort will be women ages 46-90.
Key inclusion criteria (4 listed)
- Patients are 30-90 years of age
- Patients have received a negative result from mammogram screening in past year
- Patients have no history of breast disease
- Informed consent obtained and signed
Key exclusion criteria (8 listed)
- Inability to provide informed consent
- Inability to communicate in English
- Inability to remain motionless for 15 minutes
- Any pathologies of the breast or history of breast disease
- Patients who are pregnant
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 |
|---|---|---|
| UltrasoundBreast Ultrasound | Device | Ages 30-45, Ages 46-90 |
Primary outcome
ARFI PD at 0% Strain
Time frame: Baseline imaging
Average ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
ARFI PD at 10% Strain
Time frame: Baseline imaging
Average ARFI Peak Displacement (PD) value across imaging angles with 10% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
ARFI PD at 25% Strain
Time frame: Baseline imaging
Average ARFI Peak Displacement (PD) value across imaging angles with 25% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
VisR Tau at 0% Strain
Time frame: Baseline imaging
Average VisR Tau value across imaging angles with 0% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR Tau at 10% Strain
Time frame: Baseline imaging
Average VisR Tau value across imaging angles with 10% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR Tau at 25% Strain
Time frame: Baseline imaging
Average VisR Tau value across imaging angles with 25% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RE at 0% Strain
Time frame: Baseline imaging
Average VisR RE value across imaging angles with 0% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RE at 10% Strain
Time frame: Baseline imaging
Average VisR RE value across imaging angles with 10% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RE at 25% Strain
Time frame: Baseline imaging
Average VisR RE value across imaging angles with 25% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RV at 0% Strain
Time frame: Baseline imaging
Average VisR RV value across imaging angles with 0% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RV at 10% Strain
Time frame: Baseline imaging
Average VisR RV value across imaging angles with 10% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RV at 25% Strain
Time frame: Baseline imaging
Average VisR RV value across imaging angles with 25% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
ARFI PD DoA at 0% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
ARFI PD DoA at 10% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 10% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
ARFI PD DoA at 25% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 25% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
VisR RE DoA at 0% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 0% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RE DoA at 10% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 10% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RE DoA at 25% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 25% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
VisR RV DoA at 0% Strain
Time frame: Baseline imaging
Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RV value across imaging angles with 0% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.
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 28 Mar 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Caterina Gallippi, PhD principal investigator
University of North Carolina, Chapel Hill
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 UNC Lineberger Comprehensive Cancer Center 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 4 inclusion and 8 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 28 Mar 2025. 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?
ARFI PD at 0% Strain (time frame: Baseline imaging). The study lists 19 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 28 Mar 2025.