Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01698658
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2012-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Study Overview
Official Title:
Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.
II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.
III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.
IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.
OUTLINE:
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.
II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.
III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.
IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.
OUTLINE:
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01745 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA022453 | NIH | None | https://reporter.nih.gov/quic… | View |