Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500383
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2007-07-10
Brief Title:
Breast Cancer Risk Assessment Using Optical Breast Spectroscopy OBS
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Breast Cancer Risk Assessment Using Optical Breast Spectroscopy OBS
Status:
COMPLETED
Status Verified Date:
2016-03
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:
This study aims to evaluate if a light based technique called Optical Breast Spectroscopy OBS formerly known as Transillumination Breast Spectroscopy TiBS can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study possibly reflecting changes occurring in adolescence and in the rate of breast tissue change over time possibly reflecting rate of tissue transformation from normal to ultimately malignant state
Detailed Description:
Preliminary data show Optical Breast Spectroscopy OBShas 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 OBS 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 occurring 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 eg MRI should be initiated or when more drastic primary prevention measures are recommended
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 |
|---|---|---|---|
| HC124313 | None | None | None |