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3-Dimensional Form and Soft Tissue Biomechanics of the Breast

This study has been terminated.
(Sample size too small for data analysis.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502814
First received: July 16, 2007
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: 3-D Optical Surface Scan
Procedure: Mechanical Testing
Procedure: Cutaneous Ultrasound
Procedure: Breast MRI and/or CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 3-Dimensional Form and Soft Tissue Biomechanics of the Breast

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: January 2003
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Breast Cancer.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502814

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Elisabeth Beahm, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502814     History of Changes
Other Study ID Numbers: ID01-305
Study First Received: July 16, 2007
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
3-D Optical Surface Scan
Soft Tissue Biomechanics
Mechanical Testing
Skin Ultrasound
Magnetic Resonance Imaging
CT Scan

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014