RecruitingNot Applicable

VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients

United States250 participantsStarted 2025-03-07

Plain-language summary

Purpose: This study will evaluate how measurements of tissue stiffness, viscosity, and anisotropy using non-invasive ultrasound imaging correlate with breast tumor malignancy and response to chemotherapy. Participants: Up to 200 women with benign or malignant breast tumors for arm 1 and up to 50 women undergoing neoadjuvant chemotherapy in the breast for arm 2 will be recruited. Procedures (methods): The research team will use an ultrasound scanner to acquire non-invasive elastography data from the breast of each subject, testing a range of transducer rotation angles. Transducer position will be monitored using a position sensor during imaging.

Who can participate

Age range

20 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Arm 1): * Subjects are 20-90 years of age * Subjects are female * Breast lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Breast lesion(s) have BI-RADS 4a, 4b, 4c, or 5 rating Exclusion Criteria (Arm 1): * Inability to provide informed consent * Inability to communicate in English * Inability to remain motionless for 15 minutes * Subjects with breast implants * Breast mass is deeper than 4 cm from skin surface * Subjects who are pregnant or lactating * Subjects who have pacemakers or implanted cardioverters * Subjects with a history of mastectomy * Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest * Subject is male Inclusion Criteria (Arm 2): * Subjects are 20-90 years of age * Subjects are female * Breast lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Breast lesion(s) have BI-RADS 6 rating, subject will be undergoing NAT for stage 2 or 3 malignant breast lesion(s) Exclusion Criteria (Arm 2): * Inability to provide informed consent * Inability to communicate in English * Inability to remain motionless for 15 minutes * Subjects with breast implants * Breast mass is deeper than 4 cm from skin surface * Subjects who are pregnant or lactating * Subjects who have pacemakers or implanted cardioverters * Subjects with a history of mastectomy * Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest * Subject is male

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ARFI Peak Displacement (PD) in lesion (Study Arm 1)

Timeframe: Baseline imaging

ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Elasticity (RE) in lesion (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Viscosity (RV) in lesion (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging

ARFI PD DoA in lesion (Study Arm 1)

Timeframe: Baseline imaging

Trial details

NCT IDNCT06878547

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-25

Contact for this trial

Desma Jones

919-843-9463 desma_jones@med.unc.edu

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

20 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

ARFI Peak Displacement (PD) in lesion (Study Arm 1)

Timeframe: Baseline imaging

ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Elasticity (RE) in lesion (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Viscosity (RV) in lesion (Study Arm 1)

Timeframe: Baseline imaging

VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging

ARFI PD DoA in lesion (Study Arm 1)

Timeframe: Baseline imaging