Breast Study to Determine the Ability of Non-Invasive Opt... | NCT00188682

Studies
Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.

NCT00188682

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Nov 15, 2007Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

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

Nov 2007

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

Mar 2000

Primary Completion Date

Not provided

Completion Date

Sep 2003Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 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

Nov 13, 2007

Last Update Posted Date

Nov 15, 2007Estimated

Name	Class
United States Department of Defense	FED

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 study is to learn more about the application of transillumination measurements in the determination of breast cancer risk. The goal is to demonstrate a correlation between non-invasive optical transillumination spectroscopy and parenchymal density pattern.

Detailed Description

X-ray generated images, such as mammograms, rely on the density of tissue within the breast. Tissue density are believed to be associated with proliferation of stroma and/or epithelium, which result in an increase in water associated light absorption and a decrease in lipid associated light absorption. The amount of density of the breast tissue has been shown to be an indicator of cancer risk. Thus, assessing this breast tissue density is also an important tool in determining breast cancer risk.

Optical transillumination has been shown to give information about tissue composition and tissue density. Unlike x-ray mammography which uses ionizing radiation, optical transillumination uses normal white light and is deemed safe to be used frequently for women of all ages and therefore can be used for those situations where mammography is not an option.

Normal white light is shone into the tissue and the light that leaves the breast on the other side from the source is detected and analyzed. Since the same physiological conditions that contribute to dense breast tissue, as seen in mammography, also will have unique optical signatures.

We will compare the amount of this dense tissue from the mammogram, taken with 12 months, to the density measurements found through the optical procedure. The goal is to be able to duplicate the information from the mammogram using the transillumination technique. All measurements are non-invasive and no blood samples or biopsies are required.

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

300Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be in good health and able to provide consent
Be between 35 and 75 years of age
Have no personal history of breast cancer
Have had a mammogram at The Marvelle Koffler Breast Centre at Mount Sinai Hospital within the last 12 months

Exclusion Criteria:

Have had breast biopsy
Have had breast augmentation or reduction

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Cohort recruited from the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto, Ontario, Canada)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lothar Lilge, PhD	Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ontario Cancer Institute, Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15259643	Result	Blyschak K, Simick M, Jong R, Lilge L. Classification of breast tissue density by optical transillumination spectroscopy: optical and physiological effects governing predictive value. Med Phys. 2004 Jun;31(6):1398-414. doi: 10.1118/1.1738191.
15250768	Result	Simick MK, Jong R, Wilson B, Lilge L. Non-ionizing near-infrared radiation transillumination spectroscopy for breast tissue density and assessment of breast cancer risk. J Biomed Opt. 2004 Jul-Aug;9(4):794-803. doi: 10.1117/1.1758269.

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

ID	Type	Description	Link
DOD#DAMD17-00-1-0393
UTREB#5507