Efficacy of Tomosynthesis in the BIRADS 3 Population | NCT00763100

Studies
Efficacy of Tomosynthesis in the BIRADS 3 Population

NCT00763100

Sponsor

WellSpan Health

Status

Completed

Last Update Posted

Jan 6, 2011Estimated

Enrollment

690Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Sep 26, 2008

First Submission Date that Met QC Criteria

Sep 26, 2008

First Posted Date

Sep 30, 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 5, 2011

Last Update Posted Date

Jan 6, 2011Estimated

Name	Class
Hologic, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.

Detailed Description

Not provided

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

690Estimated

Label	Type	Description	Intervention Names
Breast cancer		Patients in treatment or post-treatment for breast cancer

Measure	Description	Time Frame
to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

GROUP 1

female of any race and ethnicity
35 years or older
after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
female of any race and ethnicity
26 years or older
subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
female of any race and ethnicity
26 years or older
subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

GROUP 1, 2 and 3
subjects unable or unwilling to participate
subjects who are unable or unwilling to tolerate compression
subjects who are pregnant or who think they may be pregnant
subjects who are breastfeeding

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Three groups of patients will be enrolled:

Group 1 will enroll patients that have been categorized as a BIRADS 3 on the basis of screening and diagnostic conventional imaging work-up.

Group II will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they have undergone breast conservation therapy for breast cancer.

Group III will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they are currently undergoing primary systemic therapy.

Sampling Method

Non-Probability Sample

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