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3-Dimensional Form and Soft Tissue Biomechanics of the Breast


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

3-Dimensional Form and Soft Tissue Biomechanics of the Breast


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 0.6 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 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.


Inclusion Criteria:



1. Female

2. Greater than 18 years old.

3. Presenting complaint requires breast physical examination.

4. Free of connective tissue disorders and cutaneous malignancy on the breast.

5. Free of medical conditions that contraindicate MRI or CT scanning.

6. Willing to participate in the study and able to complete informed consent.

Exclusion Criteria:

1) Patients who do not meet inclusion criteria.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Individual 3-dimensional Form and Mechanical Properties of Patient's Breast

Outcome Time Frame:

Patient participation is approximately 1 Day for breast scans and mechanical measure, as well as ultrasound and Breast MRI/CT

Safety Issue:

No

Principal Investigator

Elisabeth Beahm, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID01-305

NCT ID:

NCT00502814

Start Date:

January 2003

Completion Date:

October 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • 3-D Optical Surface Scan
  • Soft Tissue Biomechanics
  • Mechanical Testing
  • Skin Ultrasound
  • Magnetic Resonance Imaging
  • CT Scan
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030