Histology of Functional Density in Premenopausal Breast
This study is enrolling participants by invitation only.
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01588834
First received: April 26, 2012
Last updated: March 15, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | April 26, 2012 | ||||
| Last Updated Date | March 15, 2013 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
proportion of epithelium vs stroma [ Time Frame: within 3 days of functional density assessment on MBI ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01588834 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 Premenopausal Breast | ||||
| Official Title ICMJE | Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women | ||||
| Brief Summary | The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer. |
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| Detailed Description | The specific aims are:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| 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 | ||||
| Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | October 2014 | ||||
| Estimated Primary Completion Date | April 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 to 55 Years | ||||
| 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 | NCT01588834 | ||||
| Other Study ID Numbers ICMJE | 12-000458 | ||||
| Has Data Monitoring Committee | Yes | ||||
| 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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