Breast Aesthetics by Three Dimensional Measures

NCT03578484 | Active Not Recruiting

• 1 other identifier: 44059 / 3 / MSS
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Aesthetics; 3D scanning; Aesthetic rating; Cultural Differences Aesthetics; Mammometrics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Breast measures in centimeters and degrees changes at 5 years

  10 years

• Breast measures in centimeters and degrees changes at 10 years

  15 years

• Breast measures in centimeters and degrees changes at 15 years

  16 years

• Change in breast aesthetic score at 5 years

  10 years

• Change in breast aesthetic score at 10 years

  15 years

Study Arms (1)

Volunteer female subjects

Females age 18-35 years of age. 3D breast scan will be performed and followed over 15 years. No therapeutic interventions will be performed.

Diagnostic Test: Aesthetic assessment 3D breast scanning

Interventions

Aesthetic assessment 3D breast scanning DIAGNOSTIC_TEST

Vectra TM - Canfield Inc breast scan. 3D digital photography scan.

Volunteer female subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Only the female breast aesthetics are evaluated.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be based on female volunteers between the ages of 18 and 35 of all races. This age range incorporates early to late youth. It also allows for sequential follow up. Patients with breast cancer treatment, removal of non-malignant masses, trauma, burns or dermatological diagnoses involving the breast were excluded from the study. Subjects with cosmetic surgery will be allowed to participate in the study. Volunteers will be recruited from nursing staff at Telemark Health Trust, nursing students from University Southeast Norway in Porsgrunn Norway.

You may qualify if:

• The study will be based on female volunteers between the ages of 18 and 35 of all ethnic backgrounds.

You may not qualify if:

• Patients with breast cancer treatment, removal of non-malignant masses, trauma, burns or dermatological diagnoses involving the breast are excluded from the study.

Sponsors & Collaborators

• Sykehuset Telemark: lead
• M.D. Anderson Cancer Center: collaborator
• University College of Southeast Norway: collaborator
• Skintech A/S: collaborator
• Canfield Inc: collaborator
• Oslo University Hospital: collaborator
• Karolinska Institutet: collaborator
• University of Helsinki: collaborator

Study Sites (2)

Sykehuset Telemark

Skien, Telemark, NO-3710, Norway

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (10)

• 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.

  PMID: 13230442 RESULT

• 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.

  PMID: 13335513 RESULT

• 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.

  PMID: 3659165 RESULT

• 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.

  PMID: 2729845 RESULT

• 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.

  PMID: 3737757 RESULT

• 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.

  PMID: 15838205 RESULT

• 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.

  PMID: 16978973 RESULT

• 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.

  PMID: 20048631 RESULT

• Rohrich RJ, Bolden K. Ethnic rhinoplasty. Clin Plast Surg. 2010 Apr;37(2):353-70. doi: 10.1016/j.cps.2009.11.006.

  PMID: 20206751 RESULT

• 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.

  PMID: 25028852 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lars Johan M Sandberg, MD, FACS

  STHF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: July 6, 2018
• Study Start: May 13, 2016
• Primary Completion (Estimated): March 20, 2032
• Study Completion (Estimated): March 20, 2032
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)