Tridimensional Geometric Modeling of the Breast

NCT05301998 | Completed

• 2 other identifiers: RECHMPL21_05252021-A02539-32
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The use of a personalized 3D model of the breast in the management of breast cancer would be very useful to help the surgeon better understand the three-dimensional location of tumors in the operative position and thus better plan incisions and dissection of the breast tissue. This could be achieved with the help of a 3D biomechanical breast model that ideally should integrate the patient-specific mechanical properties of all breast tissue structures. The elasticity of the skin and especially the consideration of factors that can make it vary with age has been little studied. However, the integration of this parameter would clearly increase the robustness of the 3D model. Main objective: To perform a pilot evaluation of the performance of the biomechanical model by integrating the biomechanical characteristics of the skin and the collagenous architecture of the breast, during the transition from prone to supine or lateral position. Secondary Objectives: To describe the values of skin elasticity and thickness at different points of the breast, in women in the general population To search for clinical factors predictive of elasticity and skin thickness To carry out a pilot description of the collagen architecture of the breast Participation in this study will be offered to all patients consulting the gynecology-obstetrics department of the Montpellier University Hospital and meeting the inclusion criteria-Visit 1: Inclusion and measurement of skin thickness and elasticity: Inclusion will take place during the follow-up consultation in the obstetrics gynecology department of the Montpellier University Hospital. The patient's written consent will be obtained after a reflection period at the end of the consultation. Measurements of elasticity and thickness will then be performed for each of the 200 patients. Skin elasticity: The patient will be installed in dorsal decubitus position, with her arms at her sides on an examination table. Measurements will be performed at 3 sites on one of the two breasts: at the areola, above the areola and below. The measurements will be performed by a single gynecologist in the gynecology department using a cutometer provided by a laboratory of Grenoble. It has just been used by the Dutch Cancer Institute in Amsterdam to measure the elasticity of the tongue in a clinical study including 10 patients. Three measurements will be performed at each site. One measurement corresponds to a 10-second suction time (progressive rise of the depression) followed by 5 seconds of relaxation of the measurement site. The duration of these measurements will be approximately 15 minutes. Skin thickness: The measurement of skin thickness will be performed using an ultrasound device available in the obstetrics and gynecology consultation department. The measurement will be performed at 3 sites. The duration of the measurements will be of approximately 10 minutes. Adverse events will be collected at the end of the measurements.

• Visit 2: Within 3 weeks after the first visit. Among the 200 patients, 10 patients who should benefit from a breast MRI as part of their follow-up, will have a breast MRI in 3 different positions: prone (standard protocol) and two additional acquisitions (as part of the research) in dorsal and right lateral decubitus. This examination will be scheduled in the Lapeyronie Hospital.

Conditions

Breast Cancer; Skin Elasticity

Keywords

3D geometric model; Breast surgery; Breast MRI; Breast cancer

Outcome Measures

Primary Outcomes (4)

• Measurement of skin elasticity using a cutometer

  Skin elasticity measurements will be taken at 3 sites on one of the two breasts, during their 1st visit (baseline): at the level of the areola, above the areola and below. They will be performed by a single gynecologist from the gynecology department. Measurements will be made using a cutometer. It includes a computer, tubing connected to a 10, 15 or 20 mm cup. Three measurements will be carried out on each of the sites. A measurement corresponds to a time of gradual rise in suction of 10 seconds followed by 5 seconds of relaxation of the measurement site. A method based on an inverse model will then make it possible to estimate the local elasticity (Young's modulus) of the skin.

  At baseline

• Measurement of skin thickness using an ultrasound device

  Measurements of skin thickness will be made using an ultrasound machine available in the gynecology department. They will be done at 6 sites on one of the two breasts, during their 1st visit (baseline).

  At baseline

• Collagen architecture of the breast

  Precise 3D anatomical description of different breast tissues, the position and orientation of the tissues, on 10 patients with additional MRI acquisitions, at the 2nd visit (3 weeks after the 1st visit).

  3 weeks after baseline

• 3D model

  To carry out a pilot evaluation of the performance of the biomechanical model by integrating the biomechanical characteristics of the skin and the collagenous architecture of the breast, during the transition from the prone position to the dorsal or lateral decubitus position

  Through study completion, an average of 1 year

Secondary Outcomes (9)

• Age in years

  At baseline

• Body Mass Index in kilogram per square meter

  At baseline

• Bra cup size

  At baseline

• Time in the menstrual cycle

  At baseline

• Contraception

  At baseline

Study Arms (1)

Study Group

OTHER

Measurements of elasticity and thickness will be performed for each of the 200 patients. Among the 200 patients, 10 will have a breast MRI in 3 different positions

Other: Skin and thickness measurement/breast MRI

Interventions

Skin and thickness measurement/breast MRI OTHER

Patient will be installed in dorsal decubitus position. Measurements will be performed at 3 sites on one breast: at the areola, above the areola and below. Measurements will be performed by a single gynecologist using a cutometer provided by TIMC-IMAG laboratory of Grenoble. Three measurements will be performed at each site. Duration of measurements will be approximately 15 minutes. Measurement of skin thickness will be performed using an ultrasound device available in obstetrics/gynecology consultation department. The measurement will be performed at 3 sites. The duration of the measurements will be of approximately 10 minutes. Among the 200 patients, 10 patients who should benefit from a breast MRI as part of their follow-up, will have a breast MRI in 3 different positions: prone (standard protocol) and two additional acquisitions (as part of the research) in dorsal and right lateral decubitus. This examination will be scheduled in the senology department of the Lapeyronie Hospital

Study Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Up to 18 years old
• Understanding and acceptance of the protocol

You may not qualify if:

• Person protected by law under guardianship or curatorship
• Failure to obtain free, informed and written consent after a reflection period
• A patient who is not a member or beneficiary of a national health insurance system
• Patient with a skin disease or a skin lesion
• Person deprived of liberty by judicial or administrative decision
• Application of a cream on the skin within 12 hours before the measurements

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, Outside of the US, 34090, France

Location

Related Publications (21)

• Han L, Hipwell JH, Eiben B, Barratt D, Modat M, Ourselin S, Hawkes DJ. A nonlinear biomechanical model based registration method for aligning prone and supine MR breast images. IEEE Trans Med Imaging. 2014 Mar;33(3):682-94. doi: 10.1109/TMI.2013.2294539.

  PMID: 24595342 BACKGROUND

• Han L, Hipwell JH, Tanner C, Taylor Z, Mertzanidou T, Cardoso J, Ourselin S, Hawkes DJ. Development of patient-specific biomechanical models for predicting large breast deformation. Phys Med Biol. 2012 Jan 21;57(2):455-72. doi: 10.1088/0031-9155/57/2/455. Epub 2011 Dec 15.

  PMID: 22173131 BACKGROUND

• Gefen A, Dilmoney B. Mechanics of the normal woman's breast. Technol Health Care. 2007;15(4):259-71.

  PMID: 17673835 BACKGROUND

• Escoffier C, de Rigal J, Rochefort A, Vasselet R, Leveque JL, Agache PG. Age-related mechanical properties of human skin: an in vivo study. J Invest Dermatol. 1989 Sep;93(3):353-7.

  PMID: 2768836 BACKGROUND

• Krueger N, Luebberding S, Oltmer M, Streker M, Kerscher M. Age-related changes in skin mechanical properties: a quantitative evaluation of 120 female subjects. Skin Res Technol. 2011 May;17(2):141-8. doi: 10.1111/j.1600-0846.2010.00486.x. Epub 2011 Feb 1.

  PMID: 21281361 BACKGROUND

• Kim E, Cho G, Won NG, Cho J. Age-related changes in skin bio-mechanical properties: the neck skin compared with the cheek and forearm skin in Korean females. Skin Res Technol. 2013 Aug;19(3):236-41. doi: 10.1111/srt.12020. Epub 2013 Feb 26.

  PMID: 23441628 BACKGROUND

• Ryu HS, Joo YH, Kim SO, Park KC, Youn SW. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res Technol. 2008 Aug;14(3):354-8. doi: 10.1111/j.1600-0846.2008.00302.x.

  PMID: 19159383 BACKGROUND

• Diridollou S, Vabre V, Berson M, Vaillant L, Black D, Lagarde JM, Gregoire JM, Gall Y, Patat F. Skin ageing: changes of physical properties of human skin in vivo. Int J Cosmet Sci. 2001 Dec;23(6):353-62. doi: 10.1046/j.0412-5463.2001.00105.x.

  PMID: 18498486 BACKGROUND

• Diridollou S, Black D, Lagarde JM, Gall Y, Berson M, Vabre V, Patat F, Vaillant L. Sex- and site-dependent variations in the thickness and mechanical properties of human skin in vivo. Int J Cosmet Sci. 2000 Dec;22(6):421-35.

  PMID: 18503429 BACKGROUND

• Diridollou S, Patat F, Gens F, Vaillant L, Black D, Lagarde JM, Gall Y, Berson M. In vivo model of the mechanical properties of the human skin under suction. Skin Res Technol. 2000 Nov;6(4):214-221. doi: 10.1034/j.1600-0846.2000.006004214.x.

  PMID: 11428960 BACKGROUND

• Hendriks FM, Brokken D, van Eemeren JT, Oomens CW, Baaijens FP, Horsten JB. A numerical-experimental method to characterize the non-linear mechanical behaviour of human skin. Skin Res Technol. 2003 Aug;9(3):274-83. doi: 10.1034/j.1600-0846.2003.00019.x.

  PMID: 12877691 BACKGROUND

• Kappert KDR, Connesson N, Elahi SA, Boonstra S, Balm AJM, van der Heijden F, Payan Y. In-vivo tongue stiffness measured by aspiration: Resting vs general anesthesia. J Biomech. 2021 Jan 4;114:110147. doi: 10.1016/j.jbiomech.2020.110147. Epub 2020 Nov 25.

  PMID: 33276256 BACKGROUND

• Schneider DC, Davidson TM, Nahum AM. In vitro biaxial stress-strain response of human skin. Arch Otolaryngol. 1984 May;110(5):329-33. doi: 10.1001/archotol.1984.00800310053012.

  PMID: 6712522 BACKGROUND

• Kvistedal YA, Nielsen PM. Estimating material parameters of human skin in vivo. Biomech Model Mechanobiol. 2009 Feb;8(1):1-8. doi: 10.1007/s10237-007-0112-z. Epub 2007 Nov 27.

  PMID: 18040732 BACKGROUND

• Reihsner R, Balogh B, Menzel EJ. Two-dimensional elastic properties of human skin in terms of an incremental model at the in vivo configuration. Med Eng Phys. 1995 Jun;17(4):304-13. doi: 10.1016/1350-4533(95)90856-7.

  PMID: 7633759 BACKGROUND

• Sutradhar A, Miller MJ. In vivo measurement of breast skin elasticity and breast skin thickness. Skin Res Technol. 2013 Feb;19(1):e191-9. doi: 10.1111/j.1600-0846.2012.00627.x. Epub 2012 Aug 14.

  PMID: 22891621 BACKGROUND

• Coltman CE, Steele JR, McGhee DE. Effect of aging on breast skin thickness and elasticity: implications for breast support. Skin Res Technol. 2017 Aug;23(3):303-311. doi: 10.1111/srt.12335. Epub 2016 Nov 1.

  PMID: 27800637 BACKGROUND

• Coumare R, Bouten L, Barbier F. Influence of the menstrual cycle on breast skin elasticity. Comput Methods Biomech Biomed Engin. 2015;18 Suppl 1:1912-3. doi: 10.1080/10255842.2015.1069558. Epub 2015 Aug 14. No abstract available.

  PMID: 26273846 BACKGROUND

• Mira A, Carton AK, Muller S, Payan Y. A biomechanical breast model evaluated with respect to MRI data collected in three different positions. Clin Biomech (Bristol). 2018 Dec;60:191-199. doi: 10.1016/j.clinbiomech.2018.10.020. Epub 2018 Oct 17.

  PMID: 30408760 BACKGROUND

• Duraes M, Briot N, Connesson N, Chagnon G, Payan Y, Duflos C, Rathat G, Captier G, Subsol G, Herlin C. Evaluation of breast skin and tissue stiffness using a non-invasive aspiration device and impact of clinical predictors. Clin Anat. 2024 Apr;37(3):329-336. doi: 10.1002/ca.24134. Epub 2024 Jan 4.

  PMID: 38174585 RESULT

• Duraes M, Rathat G, Coutureau J, Mandoul C, Francini S, Rebel L, Captier G, Subsol G, Herlin C. New Insights on Breast Anatomy Based on Magnetic Resonance Imaging and Surgical Observations. Clin Anat. 2026 Jan 19. doi: 10.1002/ca.70071. Online ahead of print.

  PMID: 41549904 DERIVED

Related Links

• Suction Chamber Methods for Measurement of Skin Mechanics : The New Digital Version of the Cutometer.
• In-Vivo Soft Tissues Mechanical Characterization: Volume-Based Aspiration Method Validated on Silicones

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Martha DURAES, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 31, 2022
• Study Start: March 31, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: October 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)