Quantitative Analysis of Outcomes in Breast Reconstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00677430|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2008
Last Update Posted : November 27, 2017
|Condition or disease||Intervention/treatment|
|Breast Cancer||Behavioral: Questionnaire Procedure: Digital Imaging|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery|
|Actual Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Questionnaire + Digital Imaging
A brief questionnaire packet will be completed. Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
A brief questionnaire packet will be completed.
Other Name: SurveyProcedure: Digital Imaging
Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
- Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677430
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gregory P. Reece, MD||M.D. Anderson Cancer Center|