Computed Radiography (CR) Data Collection for Mammography... | NCT00610831

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

NCT00610831

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Jan 31, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

DIRECTVIEW CR Mammography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CH-41914	Other Grant/Funding Number	Carestream Health

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding Issues

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 12, 2008

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Feb 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2018

Last Update Posted Date

Jan 31, 2018Actual

Name	Class
Carestream Health, Inc.	INDUSTRY
Eastman Kodak Company	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DIRECTVIEW CR Mammography	Device	4 views screening mammogram	DirectView CR Mammography

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Feig, MD	University of California, Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Breast Health Center, University of California Irvine Medical Center		Orange	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided