Breast CancerNCT00188591
Light Based Analysis of Developing Breast Tissue in Adolescent Girls: a Feasibility Study
An observational study of Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS) as a method to quantify breast tissue composition and density in adolescent females. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Nov 2008
- 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 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Residents of Toronto, Ontario, Canada.
Who may be able to join
- Are in good health and are able to provide assent
- Are between the ages of 10 and 14
- Are interested in participating in this study
- Are willing to come, accompanied by a parent, to the Princess Margaret Hospital
- Are able to provide consent
- Are willing to accompany your daughter to the Princess Margaret Hospital for one visit of about 45 minutes
Who cannot join
- Have had previous surgeries to the chest area
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network / Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Pilot Study to Investigate the Feasibility of Optical Spectroscopy to Quantify Bulk Breast Tissue Properties in Girls Age 10 - 14 Years
The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS) as a method to quantify breast tissue composition and density in adolescent females. Our goals include: to assess whether adolescent girls can be instructed to assist with the OS measurement procedure and to determine the OS technique's ability to show breast tissue composition and density in adolescent breast tissue.
Read the detailed description
The period between menarche and the age of first full-term pregnancy has been identified as being most crucial for establishing an individual's future breast cancer risk. Epidemiological studies further suggest exposures, such as foods and toxins, during adolescence to have a significant impact on the likelihood of transformation in the developing breast resulting in cancer later in life. Adolescent diet affects mammary development directly and indirectly by influencing the micronutrients and the hormonal status of the adolescent. The goal of this study is to investigate the feasibility of Optical Spectroscopy (OS), a method based on differential light scattering and absorption in tissue, to quantify bulk breast tissue properties in adolescent females.
- Conditions
- Breast Cancer
- Keywords
- 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 startApr 2005
- Study completionNov 2008
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- 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, Toronto, Ontario, Canada M5G 2M9
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188591
- Sponsor's protocol ID
- UHNREB#05-0154-CE
- Other IDs
- HC#92740
- Status last verified
- Nov 2008
- First submitted
- 9 Sep 2005
- Last updated
- 25 Nov 2008
- 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 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Feasibility of Optical Spectroscopy to Quantify Bulk Breast Tissue Properties in Girls Age 10 - 14 Years
- ClinicalTrials.gov ID
- NCT00188591
- Acronym / sponsor ID
- UHNREB#05-0154-CE
- Conditions
- Breast Cancer
- Keywords
- Optical Transillumination Spectroscopy, Breast Cancer Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Nov 2008 (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 proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS) as a method to quantify breast tissue composition and density in adolescent females. Our goals include: to assess whether adolescent girls can be instructed to assist with the OS measurement procedure and to determine the OS technique's ability to show breast tissue composition and density in adolescent breast tissue.
Detailed description
The period between menarche and the age of first full-term pregnancy has been identified as being most crucial for establishing an individual's future breast cancer risk. Epidemiological studies further suggest exposures, such as foods and toxins, during adolescence to have a significant impact on the likelihood of transformation in the developing breast resulting in cancer later in life. Adolescent diet affects mammary development directly and indirectly by influencing the micronutrients and the hormonal status of the adolescent. The goal of this study is to investigate the feasibility of Optical Spectroscopy (OS), a method based on differential light scattering and absorption in tissue, to quantify bulk breast tissue properties in adolescent females.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Residents of Toronto, Ontario, Canada.
Key inclusion criteria (6 listed)
- Are in good health and are able to provide assent
- Are between the ages of 10 and 14
- Are interested in participating in this study
- Are willing to come, accompanied by a parent, to the Princess Margaret Hospital
- Are able to provide consent
Key exclusion criteria (1 listed)
- Have had previous surgeries to the chest area
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 25 Nov 2008.
- 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, 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 6 inclusion and 1 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 25 Nov 2008. 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 NCT00188591, 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 25 Nov 2008.