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Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery


If you agree to take part in this study, you will be asked to fill out a brief questionnaire
packet. This packet contains questions about how you feel about your appearance and your
overall well-being. You will be asked to have photographs of your breast(s) taken with two
different types of digital cameras (2D and 3D). These are the same type of photographs
routinely taken for all patients having breast reconstructive surgery. The photographs and
measurements will be taken during your routine clinic visit. You will not be identifiable
in the photographs.

The photographs will be used to develop automated methods for evaluating the appearance and
shape of the breasts.

You may be asked to complete additional follow-up visits for this study. These visits would
take place at a regularly-scheduled clinic visit that takes place just before a surgical
procedure is planned. At these visits you would be asked to fill out another questionnaire
packet and to allow the research the research staff to repeat the photographs. The number of
follow-up visits needed would depend on your individual treatment plan. A final study visit
would take place once you feel you are finished with your breast reconstructive process. At
this point, your participation in the study would be completed. Breast reconstruction is
different for each patient. The length of time of the reconstructive process depends on the
procedure(s) that you and your surgeon have agreed upon. These options will be discussed at
your regularly scheduled clinic appointments.

This is an investigational study. A total of up to 300 patients will take part in this
study. All will be enrolled at UTMDACC.


Inclusion Criteria:



1. Female.

2. Age greater than 21 years old.

3. Candidate who has had or is planning to have breast reconstructive surgery and has at
least one breast mound.

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

5. Proficient at reading and speaking English.

Exclusion Criteria:

1. Women who have undergone previous bilateral mastectomy without reconstruction.

2. Women who are unable to stand unassisted for 2 minutes.

3. Diagnosis of serious mental illness (e.g., schizophrenia) or cognitive impairment.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gregory P. Reece, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0899

NCT ID:

NCT00677430

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Reconstruction
  • Digital Imaging
  • Questionnaire
  • Survey
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030