NCT00188721

Brief Summary

This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor which provides a better odds ratio than mammographic parenchymal density.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 12, 2011

Status Verified

August 1, 2011

Enrollment Period

2.7 years

First QC Date

September 9, 2005

Last Update Submit

August 11, 2011

Conditions

Keywords

Breast Cancer RiskOptical Transillumination SpectroscopyTransillumination Breast Spectroscopy

Study Arms (2)

1

Women with confirmed unilateral breast carcinoma or ductal carcinoma in situ (DCIS)

2

Women without radiological suspicious lesions, matched to cases by age (± 2.5 years), date of screening mammogram, and screening center.

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases and controls recruited from the Breast Imaging Clinic at Princess Margaret Hospital or the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto, Ontario, Canada)

You may qualify if:

  • Are in good health and capable of providing consent
  • Are willing to come in to the Princess Margaret Hospital for a single visit to meet with a female research assistant

You may not qualify if:

  • Have had breast augmentation or reduction
  • Have a personal history of breast cancer
  • Have had a previous bilateral fine needle aspiration or core biopsy
  • Have a breast tattoo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ontario Cancer Institute, Princess Maraget Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Ontario Cancer Institute, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (4)

  • 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.

    PMID: 15259643BACKGROUND
  • 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.

    PMID: 15250768BACKGROUND
  • 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.

    PMID: 17537757BACKGROUND
  • 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.

    PMID: 16249602BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

August 12, 2011

Record last verified: 2011-08

Locations