- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01373671
Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging (DBT)
Multi-center Case Collection Study to Create a Library of Images From Various Approved FFDM Systems and 3D Images From Siemens Inspiration Digital Breast Tomosynthesis (DBT) System for Studies in Support of the Inspiration DBT Approval
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Malvern, Pennsylvania, United States, 19355
- Siemens Medical Solutions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All subjects enrolled into the collection study must:
- Provide signed informed consent after receiving a verbal and written explanation of the purpose and nature of the study
be females, 40 years of age or older at the screening mammographic evaluation or age 30 or older presenting for a biopsy and have one of the following mammograms:
o Normal cases at screening (BI-RADS® 1, 2 and 3):
have a screening mammogram that includes the four standard screening views (RCC, RMLO, LCC and LMLO), as well as have both MLO and CC DBT scans of each breast,
o Actionable cases at screening (BI-RADS® 0, 4 or 5) with final BI-RADS® 1, 2, 3, 4 or 5:
- have a screening mammogram with four SSVs and any clinically necessary diagnostic mammographic views, such as straight lateral projections, rolled, magnification view and spot compression views, and, both MLO and CC DBT scans of each breast plus 4 SSVs repeated at the diagnostic or biopsy visit if the screening images are unavailable or were acquired more than 45 days prior to DBT acquisition,
have supporting ground-truth documentation for the final BI-RADS® assessment as follows:
- A one (1) year FFDM follow up without evidence of cancer for normal cases not undergoing biopsy
- A six (6) or twelve (12) month FFDM follow up confirming benign status for biopsy proven benign cases
- Pathology report for either benign or malignant biopsy finding
Exclusion Criteria:
Subjects with any of the following conditions or who have had the following procedures will be excluded from this study:
- Pregnant women or women who believe they may be pregnant or are trying to become pregnant.
- Mastectomy patients
- Subjects who have had lumpectomy ≤ 5 years prior to the study entry
- Inmates (in accordance with 45 CFR 46.306) or mentally disabled individuals
- BI-RADS® Category 6 (e.g., for which the mammogram was performed for the purpose of planning cancer therapy)
- BI-RADS® Category 4 or 5 without confirming pathology reports will be considered incomplete
- Subjects with mammograms that lack the required views or with views judged to be technically inadequate will be considered incomplete and the cases will not be considered for the MRMC reader studies
- Subjects being accrued from the screening population who know that they will not be in the United States or available for follow up mammograms in one year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Mammography exam
Siemens DBT scan
|
DBT scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone
Time Frame: 1 year
|
The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions.
A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.
|
1 year
|
Collaborators and Investigators
Investigators
- Agnes Lazar, Siemens Medical Solutions USA, Inc
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SMS-SP09-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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