Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547034
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker Evaluation of Compression in Control Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker Evaluation of Surface Compression in Control Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for elasticity viscosity and anisotropy To this end we will investigate the effect of applied compression during imaging on elasticity viscosity and anisotropy measurements
Participants Twenty women with negative mammograms and no history of breast disease will be recruited The subjects will be split into two cohorts of ten each the first cohort aged 30-45 and the second cohort aged 46-90 Subjects will be recruited from the Breast Imaging Division of UNC Hospitals
Procedures methods In this exploratory clinical study the investigators will attempt to demonstrate that ARFI VisR and DDAI ultrasound measurements of elasticity viscosity and anisotropy in healthy breast tissue vary based on applied pre-compression This unblinded open-label study will be conducted in 20 women with negative mammogram results and no history of breast disease
Participants Twenty women with negative mammograms and no history of breast disease will be recruited The subjects will be split into two cohorts of ten each the first cohort aged 30-45 and the second cohort aged 46-90 Subjects will be recruited from the Breast Imaging Division of UNC Hospitals
Procedures methods In this exploratory clinical study the investigators will attempt to demonstrate that ARFI VisR and DDAI ultrasound measurements of elasticity viscosity and anisotropy in healthy breast tissue vary based on applied pre-compression This unblinded open-label study will be conducted in 20 women with negative mammogram results and no history of breast disease
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 Screening is beneficial when it averts progression of disease to metastasis andor death but adverse effects to patients and unnecessary medical expense may result downstream from false positives and indiscrimination of masses that will not respond to treatment The sensitivity of digital mammography the current screening standard in the US has been reported in the range of 040 to 085 with a positive predictive value of 031 Sensitivity is increased by augmenting mammography with MRI and B-Mode ultrasound but false positive rates may also increase There exists a vital need for a screening technology that exhibits high sensitivity and specificity for cancer detection with early identification of unresponsive masses
This urgent need could be met by exploiting new imaging biomarkers Specifically the mechanical properties of breast tissue have been used for cancer detection with both elasticity and viscosity demonstrated for discriminating malignant from benign lesions Further tissue anisotropy has been shown to correlate with core biopsy result and tumor grade with large cancers significantly more anisotropic than small cancers Importantly while both MRI and ultrasound can be used to measure these biomarkers ultrasounds cost effectiveness and ease of implementation render it an efficient platform to pursue
The long-term goal of this research program is to develop a new ultrasound-based breast-screening tool to augment mammography As a critical first step toward achieving this goal the primary objective of the proposed research is to evaluate in vivo the replicability of ultrasound-derived metrics for stiffness elasticity viscosity and anisotropy These biomarkers will be measured using novel noninvasive ultrasound technologies under development in Dr Gallippis 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 These technologies have been demonstrated previously for delineating atherosclerosis muscular dystrophy and renal dysfunction
The investigators hypothesize that ultrasound-derived stiffness elasticity viscosity and anisotropy measurements will vary based on applied compression from the sonographer This is because applying compression to tissue alters its organization typically reflected by increased stiffness and viscosity and changes in mechanical anisotropy To test this hypothesis they will pursue the following specific aim
Aim 1 Quantify the change in ultrasound-derived stiffness elasticity viscosity and anisotropy measurements from applied pre-compression ARFI VisR and DDAI imaging will be performed on breast stromal tissue in 20 women with negative mammograms and no history of breast disease Changes in the ultrasound-derived metrics will be evaluated between no applied compression 10 applied strain and 25 applied strain Additionally magnitude of change in these metrics with applied strain will be compared between two age cohorts aged 30-45 vs 46-90 and between breast density levels as rated on BIRADS scale
This urgent need could be met by exploiting new imaging biomarkers Specifically the mechanical properties of breast tissue have been used for cancer detection with both elasticity and viscosity demonstrated for discriminating malignant from benign lesions Further tissue anisotropy has been shown to correlate with core biopsy result and tumor grade with large cancers significantly more anisotropic than small cancers Importantly while both MRI and ultrasound can be used to measure these biomarkers ultrasounds cost effectiveness and ease of implementation render it an efficient platform to pursue
The long-term goal of this research program is to develop a new ultrasound-based breast-screening tool to augment mammography As a critical first step toward achieving this goal the primary objective of the proposed research is to evaluate in vivo the replicability of ultrasound-derived metrics for stiffness elasticity viscosity and anisotropy These biomarkers will be measured using novel noninvasive ultrasound technologies under development in Dr Gallippis 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 These technologies have been demonstrated previously for delineating atherosclerosis muscular dystrophy and renal dysfunction
The investigators hypothesize that ultrasound-derived stiffness elasticity viscosity and anisotropy measurements will vary based on applied compression from the sonographer This is because applying compression to tissue alters its organization typically reflected by increased stiffness and viscosity and changes in mechanical anisotropy To test this hypothesis they will pursue the following specific aim
Aim 1 Quantify the change in ultrasound-derived stiffness elasticity viscosity and anisotropy measurements from applied pre-compression ARFI VisR and DDAI imaging will be performed on breast stromal tissue in 20 women with negative mammograms and no history of breast disease Changes in the ultrasound-derived metrics will be evaluated between no applied compression 10 applied strain and 25 applied strain Additionally magnitude of change in these metrics with applied strain will be compared between two age cohorts aged 30-45 vs 46-90 and between breast density levels as rated on BIRADS scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None