Survey of Optical Values of the Breast Using Radiation-Fr... | NCT00671385

Studies
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning

NCT00671385

Sponsor

Spectros Corporation

Status

Unknown status

Last Update Posted

Feb 1, 2011Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Breast Lesions
Breast Cyst
Early-Stage Breast Cancer
Benign Growth, Breast

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2009Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

May 1, 2008

First Submission Date that Met QC Criteria

May 2, 2008

First Posted Date

May 5, 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 30, 2011

Last Update Posted Date

Feb 1, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Spectros CorporationINDUSTRY

Collaborators

Name	Class
Stanford University	OTHER
University of California	OTHER
Palo Alto Medical Foundation	OTHER

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

The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.

Detailed Description

Not provided

Conditions Module

Conditions

Breast Lesions
Breast Cyst
Early-Stage Breast Cancer
Benign Growth, Breast

Keywords

screening
compositional analysis
metabolism
breast
breast cyst
breast infection
breast inflammation
lipoma
benign growth
Women without a diagnosis for a region of interest in the breast

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women 21-50 years old		Women without a diagnosis of cancer or a history of cancer.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optical normals for the breast for a variety of conditions		3 years

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic compositional standards for (a) diagnosis of a condition such as cyst, benign growth, inflammation, and/or (b) referral for additional evaluation of a region of interest.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

You must be female
You must be 21 to 50 years old
You must not have or have had breast cancer.
You must not have or have had breast implants or breast surgery
You must not have had a breast biopsy or injury, or a breast infection, in 90 days.

Exclusion Criteria:

Any one or more of the above conditions not met
Lack of informed consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Women 18-50 with who EITHER (a) have a region of interest but without a diagnosis, or (b) are healthy volunteers without breast cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lizzy van Thillo, AA	Contact	650-851-4040	549	lizzy@spectros.com
Carrie Bomarito, RN	Contact	650-851-4040	0	info@spectros.com

Overall Officials

Name	Affiliation	Role
David A Benaron, MD	Spectros Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spectros Corporation	Recruiting	Portola Valley	California	94029	United States

Type	Date	Date Unknown
Release	May 23, 2016
Reset	Jun 30, 2016

Submission Tracking

Estimated Results First Submitted Date

May 23, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 23, 2016			Jun 30, 2016

Condition Browse Module

MeSH Terms

ID	Term
D047688	Breast Cyst
D001943	Breast Neoplasms
D008413	Mastitis
D008067	Lipoma

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
CA126441
CA083597