Histology of Functional Density in Postmenopausal Breast
| Tracking Information | |||||
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| First Received Date ICMJE | November 5, 2010 | ||||
| Last Updated Date | March 15, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
proportion of epithelium vs stroma [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Relative composition of epithelium vs stroma [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ] The relative composition of epithelium vs stroma in dense tissue which appears photopenic on MBI will be compared to that of dense tissue which appears functionally active on MBI. |
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| Change History | Complete list of historical versions of study NCT01240278 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Histology of Functional Density in Postmenopausal Breast | ||||
| Official Title ICMJE | Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women | ||||
| Brief Summary | Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: breast biopsy
ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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| Gender | Female | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01240278 | ||||
| Other Study ID Numbers ICMJE | 10-004506 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Carrie Hruska, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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