MedDataX Logo

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

NCT ID: NCT00188682

Last Updated: 2007-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-03-31

Study Completion Date

2003-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Optical Transillumination Spectroscopy Transillumination Breast Spectroscopy Breast Cancer Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Department of Defense

FED

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lothar Lilge, PhD

Role: PRINCIPAL_INVESTIGATOR

Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ontario Cancer Institute, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 15259643 (View on PubMed)

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.

Reference Type RESULT
PMID: 15250768 (View on PubMed)

Simick MK, Lilge L. Optical transillumination spectroscopy to quantify parenchymal tissue density: an indicator for breast cancer risk. Br J Radiol. 2005 Nov;78(935):1009-17. doi: 10.1259/bjr/14696165.

Reference Type RESULT
PMID: 16249602 (View on PubMed)

Blackmore KM, Knight JA, Jong R, Lilge L. Assessing breast tissue density by transillumination breast spectroscopy (TIBS): an intermediate indicator of cancer risk. Br J Radiol. 2007 Jul;80(955):545-56. doi: 10.1259/bjr/26858614. Epub 2007 May 30.

Reference Type RESULT
PMID: 17537757 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DOD#DAMD17-00-1-0393

Identifier Type: -

Identifier Source: secondary_id

UTREB#5507

Identifier Type: -

Identifier Source: secondary_id

UHNREB#00-0081-C

Identifier Type: -

Identifier Source: org_study_id