NCT00695968

Brief Summary

To determine the sensitivity, specificity, and accuracy of preoperative ultrasound, elastography, mammography and breast MRI in women with dense breast tissue diagnosed with breast cancer; to test whether elastography or MRI can improve upon routine mammogram and conventional ultrasound in women with dense breast tissue.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 18, 2019

Status Verified

July 1, 2012

Enrollment Period

3.7 years

First QC Date

June 10, 2008

Last Update Submit

April 16, 2019

Conditions

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients must have a suspicious breast lesion

You may qualify if:

  • Patients must be \>= 18 and \< 80 years of age, and female.

You may not qualify if:

  • \<18 or \>80 years of age
  • Pregnant or Lactating Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Debra M Ikeda

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 18, 2019

Record last verified: 2012-07

Locations