- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589043
Computed Tomography Laser Mammography Breast Imaging Device (CTLM)
August 24, 2015 updated by: Imaging Diagnostic Systems
Computed Tomography Laser Mammography Breast Imaging Device Model 1020
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Heterogeneous or extremely dense breast patient population scheduled for biopsy
Description
Inclusion Criteria:
- Female
- 21 and over
- Heterogeneously or extremely dense breast
- Schedule for biopsy
- Gave informed consent
Exclusion Criteria:
- 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
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: David Jin, MD, Imaging Diagnostic Systems
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
October 1, 2015
Primary Completion (Anticipated)
November 1, 2016
Study Completion (Anticipated)
November 1, 2016
Study Registration Dates
First Submitted
December 24, 2007
First Submitted That Met QC Criteria
January 8, 2008
First Posted (Estimate)
January 9, 2008
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 24, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- NA at present
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.
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