Breast CancerNCT00188760
Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density
An observational study of Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- May 2004to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Cases recruited from the Reproductive Biology Unit at Mount Sinai Hospital and the University Health Network community. Controls recruited from University Health Network community and the University of Toronto community. (Toronto, Ontario, Canada)
Who may be able to join
- 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
Who cannot join
- Have had a full term pregnancy
- Have had breast biopsy
- Have had breast augmentation or reduction
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ontario Cancer Institute, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Optical Quantification of Breast Density Changes Due to Hormone Treatment, Pregnancy and Breast-feeding.
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.
Read the detailed description
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
- Breast Cancer
- Keywords
- Breast Transillumination Spectroscopy, Optical Transillumination Spectroscopy, Breast Cancer Risk
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Dr. Julia Knight (research collaborator)
- Investigators
- Lothar Lilge, PhD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188760
- Sponsor's protocol ID
- UHNREB#02-0712-C
- Other IDs
- SGKBCF#BCTR0402530, MSHREB#02-0226-E, UTREB#9313, HC#69745
- Status last verified
- Oct 2011
- First submitted
- 9 Sep 2005
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1118/1.1738191.
PubMed 15259643Simick 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.
PubMed 15250768Blackmore 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.
PubMed 17537757Simick 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.
PubMed 16249602
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Quantification of Breast Density Changes Due to Hormone Treatment, Pregnancy and Breast-feeding.
- ClinicalTrials.gov ID
- NCT00188760
- Acronym / sponsor ID
- UHNREB#02-0712-C
- Conditions
- Breast Cancer
- Keywords
- Breast Transillumination Spectroscopy, Optical Transillumination Spectroscopy, Breast Cancer Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Dr. Julia Knight (research collaborator)
- Study start
- May 2004
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cases recruited from the Reproductive Biology Unit at Mount Sinai Hospital and the University Health Network community. Controls recruited from University Health Network community and the University of Toronto community. (Toronto, Ontario, Canada)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have had a full term pregnancy
- Have had breast biopsy
- Have had breast augmentation or reduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Background: PubMed 15259643Blyschak 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.
- Background: PubMed 15250768Simick 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.
- Background: PubMed 17537757Blackmore 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.
- Background: PubMed 16249602Simick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lothar Lilge, PhD 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00188760, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2011.