RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-07
Study Completion:2028-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06878547

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 90 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Desma Jones
CONTACT
919-843-9463
desma_jones@med.unc.edu
Caterina Gallippi, PhD
CONTACT
9198436647
cmgallip@email.unc.edu

Principal Investigator

Caterina Gallippi, PhD
PRINCIPAL_INVESTIGATOR
Lampe Joint Department of Biomedical Engineering

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Caterina Gallippi, PhD, PRINCIPAL_INVESTIGATOR, Lampe Joint Department of Biomedical Engineering

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-07
Study Completion Date2028-02-24

Study Record Updates

Study Start Date2025-03-07
Study Completion Date2028-02-24

Terms related to this study

Keywords Provided by Researchers

  • Breast cancer
  • Ultrasound screening
  • Ultrasound elastography
  • ARFI Ultrasound
  • VisR Ultrasound
  • Breast cancer diagnosis
  • Malignant breast lesion
  • Benign breast lesion
  • Neoadjuvant chemotherapy
  • Non-invasive imaging
  • Tissue anisotropy
  • Elasticity
  • Viscosity

Additional Relevant MeSH Terms

  • Breast Cancer