NCT01698658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
657

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

6.1 years

First QC Date

September 26, 2012

Last Update Submit

May 24, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution

    For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.

    At time of procedure

Secondary Outcomes (3)

  • Ability of the system to identify pathological features previously identified by other imaging modalities

    At time of procedure

  • Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)

    At time of procedure

  • Sound speed as a percentage measure of dense breast tissue

    At time of procedure

Study Arms (1)

Diagnostic (SoftVue ultrasound tomography)

EXPERIMENTAL

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Other: ultrasound tomographyProcedure: magnetic resonance imaging

Interventions

ultrasound tomographyOTHER

Undergo ultrasound tomography using SoftVue

Diagnostic (SoftVue ultrasound tomography)
magnetic resonance imagingPROCEDURE

Undergo MRI of the breast

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (SoftVue ultrasound tomography)

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for mammogram, breast ultrasound and/or breast MRI
  • Breast size less than 22 cm diameter (ring diameter is 22cm)
  • Able to read or understand and provide informed consent
  • Weight \< 350lbs (patient bed max weight)
  • Non-pregnant and non-lactating
  • No open breast or chest wounds
  • No active skin infection
  • No serious medical or psychiatric illnesses that would prevent informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Alit Amit-Yousif, M.D.

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

US(1)