Collect Breast Cancer Patients' Digital Mammography Image... | NCT00749255

Studies
Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software

NCT00749255

Sponsor

WellSpan Health

Status

Terminated

Last Update Posted

Jan 19, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

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

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough personnel to conduct study at site

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Not provided

Completion Date

Jan 2011Actual

First Submitted Date

Sep 5, 2008

First Submission Date that Met QC Criteria

Sep 8, 2008

First Posted Date

Sep 9, 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 17, 2011

Last Update Posted Date

Jan 19, 2011Estimated

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 purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.

Detailed Description

The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FFDM		a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications)

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects with known breast cancer ages 18 and over
case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
source documents or mammographic interpretation must be available

Exclusion Criteria:

17 or younger

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Known breast cancer patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Misty Hicks, RTRM	Women's Imaging @ WellSpan Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Imaging @ WellSpan Health		York	Pennsylvania	17403	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