Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00610831

Enrollment

Registered

2008-02-08

Start date

2007-05-31

Completion date

2008-06-30

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.

Interventions

DEVICEDIRECTVIEW CR Mammography

4 views screening mammogram

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

Inclusion Requirements * Women age 40 to 85 * Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy) * Able to have MLO and CC views taken * Good general health * Able and willing to provide a written Informed Consent Exclusion Requirements * Under age 40 * Pregnant or suspicious of being pregnant * Breast implants * Breasts too large to be adequately positioned on a 24 x 30 cassette * Personal history of breast cancer treated with a lumpectomy * Unable or unwilling to provide a written Informed Consent form

Design outcomes

Primary

Measure	Time frame
To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.	at completion of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026