Using ultrasound to evaluate breast cancer biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.