NCT00759447

Brief Summary

Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 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

December 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

February 22, 2019

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

September 24, 2008

Last Update Submit

February 20, 2019

Conditions

Breast Cancer

Keywords

Breast cancertomosynthesis

Outcome Measures

Primary Outcomes (1)

  • Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design

    images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest

    1 year

Study Arms (2)

3D investigational imaging

Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition

Device: Investigational 3D Mammography system

3D Imaging with commercial Mammography Device

Device: Genesis and Gemini

Interventions

Genesis and GeminiDEVICE

3 dimensional breast mammography system

Also known as: Selenia Dimensions
3D Imaging with commercial Mammography Device
Investigational 3D Mammography systemDEVICE

3 dimensional breast mammography system

3D investigational imaging

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female who are undergoing screening mammography.

You may qualify if:

  • Female, any ethnic origin
  • No contraindication for diagnostic mammography

You may not qualify if:

  • Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
  • Under 30 years of age at the time of consent
  • Unable to understand and execute written informed consent

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 Design

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

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 22, 2019

Record last verified: 2015-03