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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 90 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "The purpose of the proposed research is to evaluate in vivo the feasibility of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy for clinical diagnostic breast imaging."
  • "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."
  • "The hypothesis of this study is that ultrasound-derived stiffness, elasticity, viscosity, and anisotropy measured in breast tissue will differ between patients with malignant and benign lesions, and between patients who are responsive versus non-responsive to neoadjuvant systemic therapy (NAT)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ultrasound measures of breast tissue can help show if a tumor is cancer and how it responds to chemotherapy. It measures how stiff tissue is, how it moves under pressure, and how these features change with direction. It is for women ages 20–90 with breast tumors, including women getting chemotherapy before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Women ages 20–90.
  • Both groups: The breast lump must be visible on a standard ultrasound.
  • Group 1: The lump has a BI-RADS rating of 4a, 4b, 4c, or 5, meaning scans suggest it may be cancer.
  • Group 2: The lump has a BI-RADS rating of 6, meaning cancer has been confirmed by biopsy.
  • Group 2: You have stage 2 or 3 breast cancer and will receive chemotherapy before surgery.

Who can't join

  • Both groups: You cannot give informed consent, meaning you cannot agree to join after learning about the study.
  • Both groups: You cannot communicate in English or stay still for 15 minutes.
  • Both groups: You have breast implants.
  • Both groups: The breast lump is more than 4 cm below the skin.
  • Both groups: You are pregnant or breastfeeding.
  • Both groups: You have a pacemaker or an implanted device that shocks the heart to correct its rhythm.
  • Both groups: You have had a mastectomy, which is surgery to remove a breast.
  • Both groups: You have had a biopsy or surgery at the lump's site, or surgery to remove the lump.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

NC