Breast Cancer Clinical Trial
— SENO3DOfficial title:
Tridimensional Geometric Modeling of the Breast. Interest in Creating a Generic Biomechanical Model Useful for Simulation and Surgical Prediction
Verified date | December 2022 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Montpellier | Montpellier | Outside Of The US |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
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