Optical Spectroscopic Technique to Monitor Breast Tissue Composition in Women With Genetic Risk Factors - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto University of Kansas Lund University Hospital
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00500383

Purpose

This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between women who harbor a mutation in the breast cancer susceptibility gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occuring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

Condition
Breast Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Spectroscopic Monitoring of Breast Tissue Composition in Women With Genetic Risk Factors

Further study details as provided by University Health Network, Toronto:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	900
Study Start Date:	June 2009
Estimated Study Completion Date:	April 2013

Detailed Description:

Preliminary data show Transillumination Breast Spectroscopy (TiBS) has the ability to detect tissue differences with various pathologies and age-related changes in breast tissue over a two year period. In the present study, we want to determine whether TiBS has the ability to detect optical differences between women who harbor a mutation in the breast cancer susceptibility gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). More specifically, possible differences in the breast tissue at time of enrollment into the study (reflecting changes potentially occuring in adolescence) and in the rate of breast tissue change over time (reflecting rate of tissue transformation from normal to ultimately malignant state). The overall goal is to develop a pre-screening technique to survey or monitor the risk of breast tissue and to advise the earliest point when imaging techniques (e.g. MRI) should be initiated or when more drastic primary prevention measures are recommended.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Cases are recruited from three participating high-risk screening centres: Familial Breast and Ovarian Cancer Programs at Mount Sinai Hospital and/or Princess Margaret Hospital (Toronto, Ontario, Canada), the University of Kansas Medical Center (Kansas City, Kansas, US) or Lund University (Lund, Sweden). Controls are recruited from the respective grographical locations.

Criteria

Inclusion Criteria:

BrCa carriers (cases)

Attending one of the three participating high-risk screening centres
Confirmed BrCa1 or BrCa2 mutation status through genetic testing

BrCa non-carriers (controls)

Controls from general population with pre-test Penn II BrCa1 and BrCa2 Mutation Risk Evaluation Model score < 10%
Controls from high-risk screening centre with confirmed BrCa1/2 negative status through genetic testing
Matched by age and geographical location

Exclusion Criteria:

BrCa carriers (cases)

Women with bilateral mastectomy
Inability to provide informed consent due to language or cognitive difficulties

BrCa non-carriers (controls)

Prior breast cancer
Cosmetic alteration (reduction/augmentation)
Family history of breast cancer where family member had early diagnosis (before age of 45 years)
Family history of ovarian cancer
Inability to provide informed consent due to language or cognitive difficulties

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500383

Contacts

Contact: Samantha Dick, BScH, DipHSc

416-946-4501 ext 4202

tibs@uhnresearch.ca

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Canada, Ontario
Princess Margaret Hospital/Mount Sinai Hospital
Toronto, Ontario, Canada
Sweden, Skane
Lund University
Lund, Skane, Sweden, SE-221 00

Sponsors and Collaborators

University Health Network, Toronto

University of Kansas

Lund University Hospital

Investigators

Principal Investigator:

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

More Information

Transillumination Breast Spectroscopy Research Program This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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 May 30; [Epub ahead of print]

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.

Responsible Party:	University Health Network ( Dr. Lothar Lilge )
Study ID Numbers:	UHNREB#07-0689-CE, HC#124313
Study First Received:	July 10, 2007
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00500383
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Breast Cancer Risk
BRCA1
BRCA2

Breast Cancer Susceptibility gene
Optical Transillumination Spectroscopy
Transillumination Breast Spectroscopy

Study placed in the following topic categories:

Skin Diseases
Disease Susceptibility
Breast Neoplasms
Genetic Predisposition to Disease
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009