Visibility of Lesion Characteristics With Phase Contrast... | NCT00467727

Studies
Visibility of Lesion Characteristics With Phase Contrast Mammography

NCT00467727

Sponsor

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Last Update Posted

May 1, 2012Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Phase Contrast 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

Status Module

Record Verification Date

Apr 2012

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

Apr 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Apr 29, 2007

First Submission Date that Met QC Criteria

Apr 30, 2007

First Posted Date

May 1, 2007Estimated

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

Apr 27, 2012

Last Update Posted Date

May 1, 2012Estimated

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

To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM).

Detailed Description

The ability to detect lesions in mammography before they can be felt is the benefit of using this imaging modality for screening of breast cancer. Screening mammography has been proven to decrease mortality from breast cancer. Radiologists identify abnormal breast tissue in the form of microcalcifications, masses, architectural distortion, and asymmetric density by careful assessment of the characteristics of these types of lesions using the Breast Imaging Reporting and Diagnostic System (BIRADS). BIRADS was developed to provide standardization of reporting of mammographic exams. In screening mammography, while it is possible to detect lesions, often more detailed diagnostic imaging is necessary to improve the visibility of margins and edges of lesions through magnification and compression views of the lesion of interest due to spatial resolution limitations which causes geometric blurring of edges in x-ray mammography.

If the ability to clearly see margins and edges of lesions is possible at screening mammography, this would potentially decrease the overall radiation exposure currently needed to allow radiologists to be confident of their characterizations for the majority of patients using x-ray mammography. Digital mammography was developed to improve the visibility of lesions primarily in dense breasts. The reasoning was that the improved contrast range would allow for wider range of gray level differentiation but with digital mammography comes a spatial resolution limitation that blurred edges of lesions. Phase contrast mammography (PCM) was developed to improve digital mammography by providing improvement in sharpness of edges utilizing the x-ray properties of refraction.

Comparison: Phase Contrast Mammography to X-Ray Mammography for Lesion Visibility of Diagnostic Population

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

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Phase Contrast Mammography Exam	Other: Phase Contrast Mammography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phase Contrast Mammography	Other	Standard and magnification views	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 40 years old
Female
Scheduled for diagnostic work-up including compression/magnification views of screening detected breast lesion

Exclusion Criteria:

< age 40
Male
No screening detected findings
Breast implants
Any women who is pregnant or has reason to believe she is pregnant or lactating
Women with breasts larger than the 24 x 30 cm receptor

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Etta D Pisano, MD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carolina Center for Clinical Trials, University of North Carolina		Chapel Hill	North Carolina	27599	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12727392	Background	Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1.
15973129	Background	Tanaka T, Honda C, Matsuo S, Noma K, Oohara H, Nitta N, Ota S, Tsuchiya K, Sakashita Y, Yamada A, Yamasaki M, Furukawa A, Takahashi M, Murata K. The first trial of phase contrast imaging for digital full-field mammography using a practical molybdenum x-ray tube. Invest Radiol. 2005 Jul;40(7):385-96. doi: 10.1097/01.rli.0000165575.43381.48.

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