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 range20 Years – 90 Years

SexFEMALE

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

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

ARFI PD DoA in surrounding tissue (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 range20 Years – 90 Years

SexFEMALE

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

ARFI PD DoA in surrounding tissue (Study Arm 1)

Timeframe: Baseline imaging