Clinical trial NCT00502814: 3-Dimensional Form and Soft Tissue Biomechanics of the Breast
Official title: 3-Dimensional Form and Soft Tissue Biomechanics of the Breast
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Breast Cancer
3-D Optical Surface Scan
Soft Tissue Biomechanics
Mechanical Testing
Skin Ultrasound
Magnetic Resonance Imaging
CT Scan
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Breast Cancer.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Individual 3-dimensional Form and Mechanical Properties of Patient's Breast
timeFrame: Patient participation is approximately 1 Day for breast scans and mechanical measure, as well as ultrasound and Breast MRI/CT
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Elisabeth Beahm, MD
role: PRINCIPAL_INVESTIGATOR
References: