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Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density

NCT ID: NCT00188760

Last Updated: 2011-10-07

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

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to test the ability of a technique called Transillumination Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.

Detailed Description

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Breast density is an established physical risk factor for breast cancer, applicable to the entire female population in a pre-breast-screening program and, unlike other risk factors, was shown to be affected by an intervention treatment. High breast tissue density is associated with increased risk of breast cancer. Transillumination Breast Spectroscopy (TIBS) uses a white light to provide spectral information on breast tissue density and composition (e.g. water, lipid, hemoglobin and other biomolecules). The overall goal of the TIBS program is to develop a technique that can identify individuals at high risk for breast cancer who would benefit most from improved screening methods and a risk reducing intervention (e.g. diet and lifestyle changes) and can monitor the efficacy of the risk reducing intervention itself in an individual. In a previous study, we demonstrated a high correlation between breast density assessed by TIBS and density identified by x-ray mammography. The current study is testing TIBS ability to monitor changes in an individual's breast density over time

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Be in good health and able to provide consent
* Be between 25 and 45 years of age
* Be pre-menopausal
* Are willing to come in to Princess Margaret Hospital (Toronto, Ontario, Canada) for up to 12 visits at intervals of about three months

Exclusion Criteria

* Have had a full term pregnancy
* Have had breast biopsy
* Have had breast augmentation or reduction
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role collaborator

Dr. Julia Knight (research collaborator)

UNKNOWN

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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University Health Network

Principal Investigators

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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, Ontario, Canada M5G 2M9

Locations

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Ontario Cancer Institute, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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 BACKGROUND
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 BACKGROUND
PMID: 15250768 (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 BACKGROUND
PMID: 17537757 (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 BACKGROUND
PMID: 16249602 (View on PubMed)

Other Identifiers

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SGKBCF#BCTR0402530

Identifier Type: -

Identifier Source: secondary_id

MSHREB#02-0226-E

Identifier Type: -

Identifier Source: secondary_id

UTREB#9313

Identifier Type: -

Identifier Source: secondary_id

HC#69745

Identifier Type: -

Identifier Source: secondary_id

UHNREB#02-0712-C

Identifier Type: -

Identifier Source: org_study_id