NCT00722059

Brief Summary

The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2006

Longer than P75 for early_phase_1

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

Study Start

First participant enrolled

April 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

7.5 years

First QC Date

July 23, 2008

Last Update Submit

January 31, 2014

Conditions

Breast NeoplasmsBreast Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Measure of digital tomosynthesis and digital mammography test performance.

    Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.

    3 weeks

Study Arms (1)

1

EXPERIMENTAL

Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.

Procedure: Breast Tomosynthesis

Interventions

Breast TomosynthesisPROCEDURE

3D breast imaging

1

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females 30 years of age or older.
  • Dense Breasts.
  • Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
  • Suspicious or palpable mass and scheduled for biopsy.

You may not qualify if:

  • Pregnant or lactating women.
  • Prior personal history of breast cancer.
  • Prior breast augmentation with implants or silicon injection. male patients.
  • No two view mammogram as part of breast imaging evaluation.
  • Breast density of almost entirely fatty/scattered fibroglandular densities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexis V. Nees, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

April 1, 2006

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

US(1)