Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502814
Status:
TERMINATED
Last Update Posted:
2012-02-22
First Post:
2007-07-16
Brief Title:
3-Dimensional Form and Soft Tissue Biomechanics of the Breast
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
3-Dimensional Form and Soft Tissue Biomechanics of the Breast
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sample size too small for data analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to characterize the 3-dimensional form and mechanical properties of the breast Researchers want to do this in order to develop new high technology tools for improving the diagnosis and treatment of breast cancer in women
Detailed Description:
Patients who participate in the study will have general physical and demographic information recorded Height weight age race menstrual status and bra size will all be recorded Patients will have a breast physical exam Researchers will then perform several painless tests and imaging studies to evaluate the mechanical properties of the skin and the shape and tissue composition of the breasts
Patients in this study will go through a series of evaluations as listed below
1 3-D Optical Surface Scan estimated time required 5 minutes The camera system with a safe scanning laser will be used to take 3-D digitized images of the breasts and chest Multiple images may be necessary to get a complete rendering of both breasts Each image requires less than 06 seconds to take This process is similar to the routine photography currently performed on most patients
2 Mechanical testing estimated time required 1 hour A small device will be applied with the surface of the skin at several locations on the breasts A mild suction will be applied for several seconds for each measurement This will measure how the skin tends to stretch The instruments used are very sensitive and provide the information needed with very small painless amounts of movement in the skin In addition to evaluating characteristics of the breast skin one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities
3 Skin Ultrasound estimated time required 15 minutes Patients will have a cutaneous ultrasound using the 20 MHz machine and the skin thickness will be recorded in each of the domains A trained technician will complete this exam In addition to evaluating characteristics of the breast skin one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities
4 Breast MRI andor CT estimated time required 1 hour Some patients will be scheduled for imaging of the breasts and chest using MRI andor CT These images will be taken free-of-charge as they are not required for standard of care
Participation will be over once the evaluations are complete
This is an investigational study A total of 200 patients will take part in this study All will be enrolled at M D Anderson After the first 50 patients are enrolled the results will be studied to see if the study will continue All will be enrolled at M D Anderson
Patients in this study will go through a series of evaluations as listed below
1 3-D Optical Surface Scan estimated time required 5 minutes The camera system with a safe scanning laser will be used to take 3-D digitized images of the breasts and chest Multiple images may be necessary to get a complete rendering of both breasts Each image requires less than 06 seconds to take This process is similar to the routine photography currently performed on most patients
2 Mechanical testing estimated time required 1 hour A small device will be applied with the surface of the skin at several locations on the breasts A mild suction will be applied for several seconds for each measurement This will measure how the skin tends to stretch The instruments used are very sensitive and provide the information needed with very small painless amounts of movement in the skin In addition to evaluating characteristics of the breast skin one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities
3 Skin Ultrasound estimated time required 15 minutes Patients will have a cutaneous ultrasound using the 20 MHz machine and the skin thickness will be recorded in each of the domains A trained technician will complete this exam In addition to evaluating characteristics of the breast skin one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities
4 Breast MRI andor CT estimated time required 1 hour Some patients will be scheduled for imaging of the breasts and chest using MRI andor CT These images will be taken free-of-charge as they are not required for standard of care
Participation will be over once the evaluations are complete
This is an investigational study A total of 200 patients will take part in this study All will be enrolled at M D Anderson After the first 50 patients are enrolled the results will be studied to see if the study will continue All will be enrolled at M D Anderson
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