VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
Recruiting · NCT06878547 · Observational (researchers observe without assigning treatment) · Lead sponsor: UNC Lineberger Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
1 location listed across 1 US state.
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States