Case Collection Study to Support Digital Mammography Image Software Change (LIP2SIP)

Siemens

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Mammography screening and diagnosis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756496

SMS-SP04-06

Details and patient eligibility

About

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.

Enrollment: 442 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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442 participants in 1 patient group

1

Experimental group

Treatment:

Device: Mammography screening and diagnosis