临床试验/NCT06878547

NCT06878547招募中不适用

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

UNC Lineberger Comprehensive Cancer Center2 个研究点分布在 1 个国家目标入组 250 人开始时间: 2025年3月7日最近更新: 2026年6月2日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: UNC Lineberger Comprehensive Cancer Center
入组人数: 250
试验地点: 2
主要终点: VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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. This proposed pilot study has two unblinded arms, corresponding to two aims from our NIH R01 grant.

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). To test these hypotheses, the research team will pursue the following specific aims from the R01 grant (specific aim #1 is being addressed by a different ongoing study, IRB #24-0122):

Aim #2: Correlate in vivo VisR outcomes to collagen fiber organization in malignant and benign breast masses and surrounding stroma in women, and demonstrate the clinical relevance of such to cancer diagnosis and staging. ARFI, VisR, and DDAI imaging will be performed on women with malignant or benign breast tumors to determine their diagnostic value in predicting malignancy. Results will be compared with histological assessment of collagen fiber organization.

Aim #3: Correlate in vivo VisR outcomes to pre- and post-NAT collagen fiber organization, and demonstrate the clinical relevance of such to predicting pathologic complete response (pCR) to NAT in women. ARFI, VisR, and DDAI imaging will be performed on women with malignant breast tumors undergoing neoadjuvant systemic therapy to monitor changes in mechanical properties during treatment and predict response to chemotherapy from early timepoints. Results will be compared with histological assessment of collagen fiber organization.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Other

入排标准

年龄范围: 20 Years 至 90 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•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

排除标准

•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

结局指标

主要结局

VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1)

时间窗: Baseline imaging

Average VisR RV value in area of tissue outside of the lesion. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

ARFI Peak Displacement (PD) in lesion (Study Arm 1)

时间窗: Baseline imaging

Average ARFI Peak Displacement (PD) value inside of lesion. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.

ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 1)

时间窗: Baseline imaging

Average ARFI Peak Displacement (PD) value in an area of breast tissue outside of lesion. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.

VisR Relative Elasticity (RE) in lesion (Study Arm 1)

时间窗: Baseline imaging

Average VisR RE value in lesion. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 1)

时间窗: Baseline imaging

Average VisR RE value in area of tissue outside of the lesion. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

VisR Relative Viscosity (RV) in lesion (Study Arm 1)

时间窗: Baseline imaging

Average VisR RV value in lesion. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

ARFI PD DoA in lesion (Study Arm 1)

时间窗: Baseline imaging

Ratio of maximum to minimum (DoA) of ARFI PD inside the lesion over four imaging angles

ARFI PD DoA in surrounding tissue (Study Arm 1)

时间窗: Baseline imaging

Ratio of maximum to minimum (DoA) of ARFI PD in an area of tissue outside of the lesion over four imaging angles

VisR RE DoA in lesion (Study Arm 1)

时间窗: Baseline imaging

Ratio of maximum to minimum (DoA) of VisR RE inside the lesion over four imaging angles

VisR RE DoA in surrounding tissue (Study Arm 1)

时间窗: Baseline imaging

Ratio of maximum to minimum (DoA) of VisR RE in an area of tissue outside of the lesion over four imaging angles

VisR RV DoA in lesion (Study Arm 1)

时间窗: Baseline imaging

Ratio of maximum to minimum (DoA) of VisR RV inside the lesion over four imaging angles

VisR RV DoA in surrounding tissue (Study Arm 1)

时间窗: Baseline imaging

Ratio of maximum to minimum (DoA) of VisR RV in an area of tissue outside of the lesion over four imaging angles

ARFI Peak Displacement (PD) in lesion (Study Arm 2)