Status:
COMPLETED
ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-90 years
Brief Summary
Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. Participants: Forty women with b...
Detailed Description
The primary objective of breast cancer screening is to identify early stage cancer, or precancerous lesions, at a time before symptoms emerge and when treatment is likely to result in a cure. Screenin...
Eligibility Criteria
Inclusion
- \-
- Aim 1:
- Patients are 30-90 years of age
- Patients have breast masses with BIRADS 4a, 4b, 4c, or 5 rating
- Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup
- Informed consent obtained and signed
- Aim 2:
- Patients are 30-90 years
- Patients who are or will be undergoing neoadjuvant chemotherapy (NAC) for stage 2 or 3 malignant breast lesions
- Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup
- Informed consent is obtained and signed
Exclusion
- Subjects who meet any of the exclusion criteria will be excluded from study participation for both Aim 1 and Aim 2.
- Inability to provide informed consent
- Inability to communicate in English
- Inability to remain motionless for 15 minutes
- Suspicious or malignant breast mass deeper than 3 cm from skin surface
- Previous biopsy or surgery to the site of the suspicious or malignant mass
- Patients who are pregnant
- Patients who are lactating
- Patients with a history of masectomy
- Patients with breast implants
Key Trial Info
Start Date :
May 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03785782
Start Date
May 10 2018
End Date
July 15 2021
Last Update
February 20 2025
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599