NCT00610831

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

January 12, 2008

Last Update Submit

January 29, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.

    at completion of the study

Study Arms (1)

DirectView CR Mammography

EXPERIMENTAL

Each subject will have routine clinical care imaging obtained and 4 standard mammogram views (RMLO, RCC, LMLO, LCC) using CR mammography. If routine mammograms were obtained on a day previous to enrollment in the study, those images (4 views; 2 views for mastectomy patients) will not be repeated for this study; only the CR images will be obtained.

Device: DIRECTVIEW CR Mammography

Interventions

DIRECTVIEW CR MammographyDEVICE

4 views screening mammogram

DirectView CR Mammography

Eligibility Criteria

Age40 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Breast Health Center, University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Stephen Feig, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2008

First Posted

February 8, 2008

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

US(1)