3-Dimensional Form and Soft Tissue Biomechanics of the Breast

NCT00502814 | Terminated

• 1 other identifier: ID01-305
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

1

Patients with Breast Cancer.

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

Interventions

3-D Optical Surface Scan PROCEDURE

3-D digitized images of the breasts and chest will be taken over a period of five minutes.

1

Mechanical Testing PROCEDURE

A small device with a mild suction will be used to measure how the skin tends to stretch.

1

Cutaneous Ultrasound PROCEDURE

Cutaneous ultrasound using a 20 MHz machine and the skin thickness will be recorded.

1

Breast MRI and/or CT PROCEDURE

Imaging of the breasts and chest using an MRI and/or CT scan over about one hour.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Breast Cancer.

You may qualify if:

• Female
• Greater than 18 years old.
• Presenting complaint requires breast physical examination.
• Free of connective tissue disorders and cutaneous malignancy on the breast.
• Free of medical conditions that contraindicate MRI or CT scanning.
• Willing to participate in the study and able to complete informed consent.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mechanical Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Materials Testing; Investigative Techniques

Study Officials

• Elisabeth Beahm, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: January 1, 2003
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)