LIP2SIP: Case Collection Study to Support Digital Mammography Image Software Change

• Sponsor: Siemens Medical Solutions USA - CSG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00756496
• Collaborator: (none)
• Enrollment: 442
• Arm: 1
• Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Mammography screening and diagnosis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 442 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: A Multi-center Feature Analysis Study to Compare the Diagnostic Accuracy of Siemens' Image Processing (SIP) Algorithms With Lorad's Image Processing (LIP) Algorithms in Detecting and Characterizing Breast Lesions
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Device: Mammography screening and diagnosis; Mammography screening and diagnosis

Outcome Measures

Primary Outcome Measures

1. Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis [~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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female

• 40 years

Exclusion Criteria:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Siemens Medical Solutions USA - CSG

Investigators

• Study Director: Raymond C Duhamel, Ph.D., Siemens Medical Solutions USA, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Siemens Medical Solutions USA - CSG
• ClinicalTrials.gov Identifier: NCT00756496
• Other Study ID Numbers: SMS-SP04-06
• First Posted: Sep 22, 2008
• Last Update Posted: Dec 7, 2020
• Last Verified: Nov 1, 2020

Study Results

Participant Flow

Arm/Group Title	Mammography Exam
Arm/Group Description	Full Field Digital Mammography exam
Period Title: Overall Study
STARTED	442
COMPLETED	442
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	FFDM Mammography Examination
Arm/Group Description	Screening or diagnostic mammography exam.
Overall Participants	442
Age, Customized (Count of Participants)
>=40 years old	442 100%
Sex/Gender, Customized (Count of Participants)
Female	442 100%
Region of Enrollment (Count of Participants)
United States	442 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis
Description	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.
Time Frame	~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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFDM Mammography Exam - LIP Algorithm	FFDM Mammography Exam - SIP Algorithm
Arm/Group Description	Screening or diagnostic Full Field Digital Mammography (FFDM) exam	The same 130 raw data images were externally reprocessed with the Siemens processing algorithm.
Measure Participants	130	130
Measure breasts	260	260
Mean (Standard Error) [probability]	0.884 (0.008)	0.880 (0.008)

Adverse Events

Arm/Group Title	Mammography Exam
Arm/Group Description	FFDM screening or diagnostic mammography exam
All Cause Mortality
	Mammography Exam
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Mammography Exam
	Affected / at Risk (%)	# Events
Total	0/442 (0%)
Other (Not Including Serious) Adverse Events
	Mammography Exam
	Affected / at Risk (%)	# Events
Total	0/442 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.