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Trial Title:
Computed Tomography Laser Mammography Breast Imaging Device
NCT ID:
NCT00589043
Condition:
Breast Cancer
Study type:
Observational
Overall status:
Unknown status
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.
Criteria for eligibility:
Study pop:
Heterogeneous or extremely dense breast patient population scheduled for biopsy
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2015
Completion date:
November 2016
Lead sponsor:
Agency:
Imaging Diagnostic Systems
Agency class:
Industry
Source:
Imaging Diagnostic Systems
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00589043
