Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging

NCT01373671 | Completed Results

• 1 other identifier: SMS-SP09-01
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on various commercially available Full Field Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.

Conditions

Breast Cancer

Keywords

Mammography; Screening; Diagnostic

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (1)

Mammography exam

OTHER

Siemens DBT scan

Device: SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM

Interventions

SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM DEVICE

DBT scan

Mammography exam

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siemens Medical Solutions USA - CSG: lead

Study Sites (1)

Siemens Medical Solutions

Malvern, Pennsylvania, 19355, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Disease

Interventions

Mammography; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Siemens Medical Solutions USA, Inc.

lesley.ewing@siemens.com

610-448-6468

Study Officials

• Agnes Lazar

  Siemens Medical Solutions USA, Inc

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 7, 2020
• Results First Posted: January 13, 2017

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)