Using ultrasound to evaluate breast cancer biomarkers
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
UNC Lineberger Comprehensive Cancer Center · NCT06878547
This study is testing whether special ultrasound techniques can help doctors understand how breast tumors behave and respond to chemotherapy in women with either benign or malignant tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06878547 on ClinicalTrials.gov |
What this trial studies
This study evaluates the correlation between non-invasive ultrasound measurements of tissue stiffness, viscosity, and anisotropy with breast tumor malignancy and response to chemotherapy. It involves two arms: one with women having benign or malignant breast tumors and another with women undergoing neoadjuvant chemotherapy. The research utilizes advanced ultrasound technologies, including Acoustic Radiation Force Impulse (ARFI) and Viscoelastic Response (VisR) ultrasound, to gather data on breast tissue characteristics. The goal is to determine how these ultrasound-derived metrics can aid in cancer diagnosis and staging.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-90 with sonographically visible breast lesions rated BI-RADS 4a, 4b, 4c, or 5, or those with BI-RADS 6 lesions undergoing neoadjuvant chemotherapy.
Not a fit: Patients who may not benefit include those with breast implants, a history of mastectomy, or those unable to provide informed consent.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for better diagnosing and staging breast cancer, potentially improving treatment outcomes.
How similar studies have performed: Other studies have shown promise in using ultrasound technologies for breast cancer diagnostics, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Caterina Gallippi, PhD — Lampe Joint Department of Biomedical Engineering
- Study coordinator: Desma Jones
- Email: desma_jones@med.unc.edu
- Phone: 919-843-9463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast cancer, Ultrasound screening, Ultrasound elastography, ARFI Ultrasound, VisR Ultrasound, Breast cancer diagnosis, Malignant breast lesion