Clinical trial NCT01061138: Xpress Digital Mammography System Images for Computer Aided Detection Development
Official title: A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
screening mammograms
breast biopsy
Lead sponsor: Konica Minolta Medical Imaging, USA
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 597
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To achieve the goal of 107 cases with biopsy-proven cancer, it is expected that approximatley 720 patients undergoing breast biopsy will need to be enrolled in the study. In addition, we will enroll up to 330 patients from a screening population.

Brief summary: The primary objective of this study is to acquire digital mammography images produced by the Xpress Digital Mammography System in order to develop Computer Aided Detection software and systems.

Detailed description: The proposed study is an image acquisition study of mammograms produced by the investigational digital system. Women who meet the selection criteria and who agree to participate in the study will be imaged with the Xpress Digital Mammography System at the clinical sites. These images will be provided to CAD development companies to conduct their own development and testing. The CAD development companies will be responsible for submitting their results to the FDA for marketing approval of their CAD systems.

Patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. The intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. All cancers found will be used in the study. It is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. In addition, approximately 330 cases will be drawn from a screening population. The negative status of the screening cases will be established by selecting only cases classified as BIRADS 1 or 2, and have a negative mammogram at one year follow-up. All images collected will be utilized to develop and test the CAD systems, and may be used for further product development.

Eligibility criteria: Inclusion Criteria

Cases selected for the study must meet all of the following criteria:

* Female
* Scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings
* Any ethnic origin

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

* Any contraindication to mammography
* Pregnant or suspicion of being pregnant, or nursing
* Patients with palpable lesions
* Patients with internal breast markers in the region of interest
* Breast implants, without displaced views
* Significant recent breast trauma/acute mastitis
* Patient has previously undergone an excisional breast biopsy
* Patients with a history of breast cancer
* Unable or unwilling to give consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: Waterbury Hospital
state: Connecticut
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Greenville
country: United States
facility: Greenville Hospital Systems
state: South Carolina
city: San Antonio
country: United States
facility: University of Texas San Antonio
state: Texas
Study officials:
affiliation: Medical University of South Carolina
name: Etta Pisano, MD
role: PRINCIPAL_INVESTIGATOR
References: