Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
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ClinicalTrials.gov Identifier: NCT00535184 |
Recruitment Status
:
Completed
First Posted
: September 26, 2007
Last Update Posted
: March 22, 2012
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Sponsor:
GE Healthcare
Information provided by (Responsible Party):
GE Healthcare
Tracking Information | ||||
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First Submitted Date | September 24, 2007 | |||
First Posted Date | September 26, 2007 | |||
Last Update Posted Date | March 22, 2012 | |||
Study Start Date | August 2007 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00535184 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy | |||
Official Title | A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy | |||
Brief Summary | Comparison of the ability of DBT and FFDM to detect breast cancer. | |||
Detailed Description | Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Women referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic | |||
Condition | Breast Cancer | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment |
220 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | February 2010 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number | NCT00535184 | |||
Other Study ID Numbers | GE 190-003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | GE Healthcare | |||
Study Sponsor | GE Healthcare | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | GE Healthcare | |||
Verification Date | March 2012 |