CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled / 200 target
Drug / intervention
Skin and thickness measurement/breast MRIother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05301998
NCT05301998N/ACompletedHigh Momentum (3.9/mo)Completion was 46mo ago

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

University Hospital, Montpellier·interventional·Posted Mar 31, 2022·Updated Jun 12, 2026

In Brief

A clinical study evaluating Skin and thickness measurement/breast MRI for Breast Cancer and Skin Elasticity. Completed, enrolled 200 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 31, 2022
Enrollment StartMar 31, 2022
Primary CompletionAug 22, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.3 years ago

Arms & Interventions

Study Groupother

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 MRIother

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