3-Dimensional Form and Soft Tissue Biomechanics of the Breast
|ClinicalTrials.gov Identifier: NCT00502814|
Recruitment Status : Terminated (Sample size too small for data analysis.)
First Posted : July 18, 2007
Last Update Posted : February 22, 2012
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: 3-D Optical Surface Scan Procedure: Mechanical Testing Procedure: Cutaneous Ultrasound Procedure: Breast MRI and/or CT|
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.
- 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 0.6 seconds to take. This process is similar to the routine photography currently performed on most patients.
- 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.
- 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.
- Breast MRI and/or CT (estimated time required: 1 hour) Some patients will be scheduled for imaging of the breasts and chest using MRI and/or 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 Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||3-Dimensional Form and Soft Tissue Biomechanics of the Breast|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Patients with Breast Cancer.
Procedure: 3-D Optical Surface Scan
3-D digitized images of the breasts and chest will be taken over a period of five minutes.Procedure: Mechanical Testing
A small device with a mild suction will be used to measure how the skin tends to stretch.Procedure: Cutaneous Ultrasound
Cutaneous ultrasound using a 20 MHz machine and the skin thickness will be recorded.Procedure: Breast MRI and/or CT
Imaging of the breasts and chest using an MRI and/or CT scan over about one hour.
- Individual 3-dimensional Form and Mechanical Properties of Patient's Breast [ Time Frame: Patient participation is approximately 1 Day for breast scans and mechanical measure, as well as ultrasound and Breast MRI/CT ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502814
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elisabeth Beahm, MD||M.D. Anderson Cancer Center|