Case Collection Study to Support Digital Mammography Image Software Change

NCT00756496 | Completed Results

• 1 other identifier: SMS-SP04-06
• Study Type: interventional
• Target: 442
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis

  The primary objective of this study was to demonstrate non-inferiority of the Siemens' processing algorithm to Lorad's processing algorithm with regards to readers' diagnostic accuracy in detecting and characterizing breast lesions. The non-inferiority analyses were performed by comparing the area under the ROC curve (AUC) for the two algorithms \& to compare false positive marks per subject. The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. It shows in a graphical way the trade-off between clinical sensitivity and specificity for every possible cut-off for a test, and gives an idea about the benefit of using the test in question. The higher the total area under the curve, the greater the predictive power of the reader assessments. A breast-based analysis was used for the primary AUC comparison in order to obtain additional power by having more normal/benign breasts.

  ~1 year. Women with negative or biopsy benign findings at baseline (study entry) were followed for 1 year to confirm the negative status at 1-year follow-up mammography exam. Women diagnosed with cancer were not followed up.

Study Arms (1)

1

EXPERIMENTAL

Device: Mammography screening and diagnosis

Interventions

Mammography screening and diagnosis DEVICE

Mammography screening and diagnosis

1

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• \> 40 years

You may not qualify if:

• Pregnant women, or women who may become pregnant
• Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
• Palpable lesion or one that is visible by another modality
• Inmates

Sponsors & Collaborators

• Siemens Medical Solutions USA - CSG: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Milind Dhamankar
• Organization: Siemens Medical Solutions USA, Inc.

milind.dhamankar@siemens-healthineers.com

+1 (610) 448-6467

Study Officials

• Raymond C Duhamel, Ph.D.

  Siemens Medical Solutions USA, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: December 7, 2020
• Results First Posted: December 7, 2020

Record last verified: 2020-11