Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188682
Status:
COMPLETED
Last Update Posted:
2007-11-15
First Post:
2005-09-09
Brief Title:
Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Optical Transillumination Spectroscopy of Breast Tissue in Pre- and Post-Menopausal Women
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn more about the application of transillumination measurements in the determination of breast cancer risk The goal is to demonstrate a correlation between non-invasive optical transillumination spectroscopy and parenchymal density pattern
Detailed Description:
X-ray generated images such as mammograms rely on the density of tissue within the breast Tissue density are believed to be associated with proliferation of stroma andor epithelium which result in an increase in water associated light absorption and a decrease in lipid associated light absorption The amount of density of the breast tissue has been shown to be an indicator of cancer risk Thus assessing this breast tissue density is also an important tool in determining breast cancer risk
Optical transillumination has been shown to give information about tissue composition and tissue density Unlike x-ray mammography which uses ionizing radiation optical transillumination uses normal white light and is deemed safe to be used frequently for women of all ages and therefore can be used for those situations where mammography is not an option
Normal white light is shone into the tissue and the light that leaves the breast on the other side from the source is detected and analyzed Since the same physiological conditions that contribute to dense breast tissue as seen in mammography also will have unique optical signatures
We will compare the amount of this dense tissue from the mammogram taken with 12 months to the density measurements found through the optical procedure The goal is to be able to duplicate the information from the mammogram using the transillumination technique All measurements are non-invasive and no blood samples or biopsies are required
Optical transillumination has been shown to give information about tissue composition and tissue density Unlike x-ray mammography which uses ionizing radiation optical transillumination uses normal white light and is deemed safe to be used frequently for women of all ages and therefore can be used for those situations where mammography is not an option
Normal white light is shone into the tissue and the light that leaves the breast on the other side from the source is detected and analyzed Since the same physiological conditions that contribute to dense breast tissue as seen in mammography also will have unique optical signatures
We will compare the amount of this dense tissue from the mammogram taken with 12 months to the density measurements found through the optical procedure The goal is to be able to duplicate the information from the mammogram using the transillumination technique All measurements are non-invasive and no blood samples or biopsies are required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTREB5507 | None | None | None |
| DODDAMD17-00-1-0393 | None | None | None |