NCT00535184

Brief Summary

Comparison of the ability of DBT and FFDM to detect breast cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

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

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

2.5 years

First QC Date

September 24, 2007

Last Update Submit

March 21, 2012

Conditions

Breast Cancer

Keywords

MammographymammogrambreastAbnormal and normal breast tissue

Eligibility Criteria

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

Women referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic

You may qualify if:

  • Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
  • Able and willing to comply with study procedures, and have signed and dated the informed consent form
  • Surgically sterile or postmenopausal

You may not qualify if:

  • Pregnant or trying to become pregnant
  • Has signs or symptoms of breast cancer
  • Has been previously included in this study
  • Has breast implants
  • Has a history of breast cancer and is in active treatment
  • Has breasts too large to be adequately positioned for the DBT examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsAntisocial Personality Disorder

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPersonality DisordersMental Disorders

Study Officials

  • Amy Longcore

    GE Healthcare

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 22, 2012

Record last verified: 2012-03