Breast Cancer Clinical Trial
Official title:
Breast Aesthetics by Three Dimensional Measures - A Transatlantic Evaluation of Beauty Ideals Using 3D Scanning and Mammometrics.
Verified date | April 2023 |
Source | Sykehuset Telemark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Traditionally the measures of the optimally aesthetic breast have been assumed to be static and to represent universal values (1). Measures developed for optimal aesthetic results in breast reduction were derived from brassiere patterns and then applied universally (2). These early and important papers still strongly influence the view of the aesthetics of the breast despite the lack of individualisation and proportion. To create satisfying results for specific patients, optimal proportions angles and relative measures are needed for each patient. The study will clarify theses measures and provide important guidelines for surgeons.The data will also help define optimal proportional aesthetics in the individual patient. The concept of universal beauty is unrealistic. It has always been taken for granted that aesthetic values from all cultures are similar. Using 3D scanning on volunteers of youthful age offers a complex set of data that may distinguish fine differences in aesthetic ideals in different cultures. Little is known about how life events and life-style factors affect breast aesthetics. To follow a population with 3D scans over 5, 10 and 15 years will allow aesthetic ratings to be correlated with life events such as pregnancy, childbirth, breast-feeding and life style factors such as smoking. The study will improve the understanding of breast aesthetics in general, in different cultures and in relation to life events and life style factors. No similar studies have previously been performed.
Status | Active, not recruiting |
Enrollment | 32 |
Est. completion date | March 20, 2032 |
Est. primary completion date | March 20, 2032 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - The study will be based on female volunteers between the ages of 18 and 35 of all ethnic backgrounds. Exclusion Criteria: - Patients with breast cancer treatment, removal of non-malignant masses, trauma, burns or dermatological diagnoses involving the breast are excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo | |
Norway | Sykehuset Telemark | Skien | Telemark |
Lead Sponsor | Collaborator |
---|---|
Sykehuset Telemark | Canfield Inc, Karolinska Institutet, M.D. Anderson Cancer Center, Oslo University Hospital, Skintech A/S, University College of Southeast Norway, University of Helsinki |
Norway,
Li Z, Unger JG, Roostaeian J, Constantine F, Rohrich RJ. Individualized Asian rhinoplasty: a systematic approach to facial balance. Plast Reconstr Surg. 2014 Jul;134(1):24e-32e. doi: 10.1097/PRS.0000000000000294. — View Citation
Losken A, Seify H, Denson DD, Paredes AA Jr, Carlson GW. Validating three-dimensional imaging of the breast. Ann Plast Surg. 2005 May;54(5):471-6; discussion 477-8. doi: 10.1097/01.sap.0000155278.87790.a1. — View Citation
Loughry CW, Sheffer DB, Price TE Jr, Lackney MJ, Bartfai RG, Morek WM. Breast volume measurement of 248 women using biostereometric analysis. Plast Reconstr Surg. 1987 Oct;80(4):553-8. doi: 10.1097/00006534-198710000-00013. — View Citation
Loughry CW, Sheffer DB, Price TE, Einsporn RL, Bartfai RG, Morek WM, Meli NM. Breast volume measurement of 598 women using biostereometric analysis. Ann Plast Surg. 1989 May;22(5):380-5. doi: 10.1097/00000637-198905000-00002. — View Citation
PENN J. Breast reduction. Br J Plast Surg. 1955 Jan;7(4):357-71. doi: 10.1016/s0007-1226(54)80046-4. No abstract available. — View Citation
Rohrich RJ, Bolden K. Ethnic rhinoplasty. Clin Plast Surg. 2010 Apr;37(2):353-70. doi: 10.1016/j.cps.2009.11.006. — View Citation
Smith DJ Jr, Palin WE Jr, Katch VL, Bennett JE. Breast volume and anthropomorphic measurements: normal values. Plast Reconstr Surg. 1986 Sep;78(3):331-5. doi: 10.1097/00006534-198609000-00008. — View Citation
Tepper OM, Small K, Rudolph L, Choi M, Karp N. Virtual 3-dimensional modeling as a valuable adjunct to aesthetic and reconstructive breast surgery. Am J Surg. 2006 Oct;192(4):548-51. doi: 10.1016/j.amjsurg.2006.06.026. — View Citation
Tepper OM, Unger JG, Small KH, Feldman D, Kumar N, Choi M, Karp NS. Mammometrics: the standardization of aesthetic and reconstructive breast surgery. Plast Reconstr Surg. 2010 Jan;125(1):393-400. doi: 10.1097/PRS.0b013e3181c4966e. No abstract available. — View Citation
WISE RJ. A preliminary report on a method of planning the mammaplasty. Plast Reconstr Surg (1946). 1956 May;17(5):367-75. doi: 10.1097/00006534-195605000-00004. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast aesthetic score in Scandinavia | Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the most pleasant aesthetics. |
5 years | |
Primary | Breast measures in centimeters and degrees in Scandinavia | The highest and lowest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions. |
5 years | |
Primary | Breast aesthetic score in USA | Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the most pleasant aesthetics in the USA. |
5 years | |
Primary | Breast measures in centimeters and degrees in USA | The highest and lowest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions for USA. |
5 years | |
Secondary | Breast measures in centimeters and degrees changes at 5 years | The highest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions to detect change after 5 years. |
10 years | |
Secondary | Breast measures in centimeters and degrees changes at 10 years | The highest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions to detect change after 10 years. |
15 years | |
Secondary | Breast measures in centimeters and degrees changes at 15 years | The highest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions to detect change after 15 years. |
16 years | |
Secondary | Change in breast aesthetic score at 5 years | Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the change of aesthetics over 5 years. |
10 years | |
Secondary | Change in breast aesthetic score at 10 years | Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the change of aesthetics over 10 years. |
15 years | |
Secondary | Change in breast aesthetic score at 15 years | Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the change of aesthetics over 15 years. |
16 years |
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