Tridimensional Geometric Modeling of the Breast (SENO3D)

Tridimensional Geometric Modeling of the Breast. Interest in Creating a Generic Biomechanical Model Useful for Simulation and Surgical Prediction

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Skin Elasticity
• Intervention / Treatment: Other: Skin and thickness measurement/breast MRI

Detailed Description

Breast cancer is the most common cancer in France. Its screening and diagnosis use mammography, ultrasound and MRI. These imaging only show the topography of the tumors in the breast volume in two dimensions (2D). The surgeon must then mentally reconstruct the three-dimensional (3D) anatomy of the breast before planning the surgery.The use of a personalized 3D model of the breast would be very useful to help the surgeon to better understand the three-dimensional localization of the tumors in the operative position and thus to better plan the incisions and the dissection of the breast tissue, preserving the maximum of healthy tissue but also being more relevant in the oncological aspect.

This could be achieved with the help of a 3D biomechanical model of the breast which should ideally integrate the subject-specific mechanical properties of all the tissue structures of the breast. However, obtaining a model of the breast is very difficult due to the complexity and diversity of the 3D geometry of the structures and their highly heterogeneous mechanical character. All breast tissues (skin, connective tissue, mammary gland, fat, pectoral muscle) must be modeled. For this, their mechanical behavior must be known. As biomechanical properties vary according to ex-vivo and in-vivo conditions, it is important to obtain in-vivo measurements.

The biomechanical properties of the breast skin have been little studied. The integration of the mechanical parameters of the skin would thus clearly increase the robustness of a 3D model.

Some studies have focused on skin elasticity, mainly on the arms and face. Several non-invasive measurement techniques of the biomechanical properties of the skin have been tested: suction test, torsion test, bi-axial test, and multi-axial test. These techniques may be dependent on the experimental conditions: tension application technique, probe size, skin thickness, ... Among these procedures, suction tests are considered as a reference technique, non-invasive and easy to use, for the measurement of skin elasticity.

The mobility and deformation of the breast skin make it difficult to obtain accurate measurements of biomechanical properties. Sutradhar et al studied these properties in 23 women: variations in elasticity were found for different regions of the breast; lying or standing did not appear to have an impact. In 2016, Coltman et al conducted a study on breast skin elasticity and thickness involving 339 women. Regarding factors that may influence skin elasticity, Coltman et al found a decrease in skin elasticity with age. This effect was not found in the study by Sutradhar et al. A study of 15 women showed a variation in skin elasticity of the breast according to the cycle and whether or not they were taking contraception.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 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 (installation of the patient - installation of the material - realization of the 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 t the Lapeyronie Hospital.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Outside Of The US
    • Montpellier, Outside Of The US, France, 34090
      • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Study Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age in years	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
Body Mass Index in kilogram per square meter	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
Bra cup size	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
Time in the menstrual cycle	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
Contraception	Presence and type of contraception. Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
Menopausal status	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
History of breast radiotherapy	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
Breastfeeding history	Breastfeeding history after their potential pregnancies. Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline
History of breast surgery	Evaluate the potential predictive factors of the biomechanical characteristics of the skin.	At baseline

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Martha DURAES, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; Breast surgery; Breast MRI; 3D geometric model
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RECHMPL21_0525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No