A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
February 20, 2019 updated by: Hologic, Inc.
A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects.
The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems.
Information obtained from the study will be used to determine endpoints for a future larger study.
Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
Study Type
Observational
Enrollment (Actual)
240
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female who are undergoing screening mammography.
Description
Inclusion Criteria:
- Female, any ethnic origin
- No contraindication for diagnostic mammography
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
3D investigational imaging
Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition
|
3 dimensional breast mammography system
|
|
3D Imaging with commercial Mammography Device
|
3 dimensional breast mammography system
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
September 24, 2008
First Submitted That Met QC Criteria
September 24, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Actual)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.