NCT00589043

Brief Summary

The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Status
unknown

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

December 24, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
7.7 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

December 24, 2007

Last Update Submit

August 24, 2015

Conditions

Breast Cancer

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heterogeneous or extremely dense breast patient population scheduled for biopsy

You may qualify if:

  • Female
  • and over
  • Heterogeneously or extremely dense breast
  • Schedule for biopsy
  • Gave informed consent

You may not qualify if:

  • Mammogram not performed within the last 60 days
  • Open lesions on the breast
  • Previous breast biopsy within 60 days of the CTLM scan
  • Surgical deformity of breasts
  • Commercial Tattoos
  • Protoporphyria
  • Lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Jin, MD

    Imaging Diagnostic Systems

    STUDY CHAIR

Central Study Contacts

Debra Wood

CONTACT

954-581-9800dwood@imds.com

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2007

First Posted

January 9, 2008

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

August 25, 2015

Record last verified: 2015-08