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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

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About this study

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.

Condition
Breast Cancer
Tested
Ultrasound
Sponsor
UNC Lineberger Comprehensive Cancer Center

Who can join

Age
20 to 90 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 20 years
  • Maximum age: 90 years
  • Eligible sex: Female
  • Study condition: Breast Cancer
  • 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
  • Breast lesion(s) have BI-RADS 6 rating, subject will be undergoing NAT for stage 2 or 3 malignant breast lesion(s)

Exclusion 10

  • 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

1 site, 1 recruiting

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.