Tridimensional Geometric Modeling of the Breast

Breast Cancer Clinical Trial

— SENO3D  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05301998
• Other study ID #: RECHMPL21_0525
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Skin Elasticity

Intervention

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

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier	Outside Of The US

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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