CompletedNot Applicable

Tridimensional Geometric Modeling of the Breast

France200 participantsStarted 2022-03-31

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study focused on measuring things like skin elasticity, skin thickness, and collagen architecture of the breast — how might the data collected in a study like this actually affect the way my own breast cancer treatment or surgery is planned?
2Since this trial is already completed, would it be worth asking if my care team has access to any findings or 3D modeling techniques from this kind of research that could be applied in my case?
3The study used tools like a cutometer and ultrasound to build a 3D model of the breast — is this type of detailed skin and tissue mapping something that's done as part of my current evaluation, and if not, should it be?
4Collagen architecture was one of the things being measured here — can you explain how the structure of breast tissue and collagen might influence my treatment options or surgical outcomes?
5Given that this study looked at skin elasticity alongside breast cancer, is there anything about my own skin or tissue characteristics that could affect decisions about surgery, reconstruction, or recovery that we should be discussing now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of skin elasticity using a cutometer

Timeframe: At baseline

Measurement of skin thickness using an ultrasound device

Timeframe: At baseline

Collagen architecture of the breast

Timeframe: 3 weeks after baseline

3D model

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT05301998

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-22

View on ClinicalTrials.gov More Breast Cancer trials