Adjunctive Efficacy Study Of The SoftScan® Optical Breast... | NCT00267449

Studies
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

NCT00267449

Sponsor

ART Advanced Research Technologies Inc.

Status

Unknown status

Last Update Posted

Sep 11, 2007Estimated

Enrollment

950Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

SoftScan Optical Breast Imaging System

Countries

United States
Canada

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 19, 2005

First Submission Date that Met QC Criteria

Dec 19, 2005

First Posted Date

Dec 21, 2005Estimated

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

Sep 10, 2007

Last Update Posted Date

Sep 11, 2007Estimated

Description Module

Brief Summary

The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone.

Detailed Description

Prospective, serially-recruited, blinded and unblinded, validation study to test that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone. Healthy volunteers and patients scheduled for tissue biopsy/excision of a suspicious breast lesion will be enrolled. Reader Studies will be performed in which interpreting investigators will perform blinded mammography interpretations, and reinterpretations of mammography and SoftScan interpretations. Diagnostic accuracy will be calculated using tissue histopathology as the reference standard.

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

950Estimated

Name	Type	Description	Arm Group Labels	Other Names
SoftScan Optical Breast Imaging System	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women between the ages of 20 and 80 years of age, who are either healthy or who are scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion for histopathologic diagnosis.

Exclusion Criteria:

For the Healthy Volunteers Population,

subjects with a history of minor breast procedures involving either breast;
subjects with a history of major breast procedures involving either breast;
subjects with a history of significant acute breast abnormalities involving either breast; and
subjects with a history of significant chronic breast abnormalities involving either breast; and

For Referred For Biopsy Population,

subjects with a history of minor breast procedures involving either breast that were performed within 6 months prior to enrollment or which have not completed active healing at the time of enrollment;
subjects with a history of major breast procedures involving either breast;
subjects with a history of significant acute breast abnormalities involving either breast which have not completed active healing or resolution within 6 months prior to enrollment; and
subjects with a history of significant chronic breast abnormalities involving either breast.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Margaret Polyzos	Contact	(514) 832-0777	267	mpolyzos@art.ca

Overall Officials

Name	Affiliation	Role
Joseph G Kozikowski, MD	ART Advanced Research Technologies Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California-San Diego - Rebecca and John Moores Cancer Center	Recruiting	La Jolla	California	92093	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16023382	Background	Intes X. Time-domain optical mammography SoftScan: initial results. Acad Radiol. 2005 Aug;12(8):934-47. doi: 10.1016/j.acra.2005.05.006.

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