Breast CancerSENO 3DNCT05301998
Tridimensional Geometric Modeling of the Breast
A study testing Skin and thickness measurement/breast MRI in people with Breast Cancer and Skin Elasticity, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Skin Elasticity
- What is being tested?
- Skin and thickness measurement/breast MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Up to 18 years old
- Understanding and acceptance of the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Breast Cancer, Skin Elasticity
- Being tested
- Skin and thickness measurement/breast MRI
- Keywords
- 3D geometric model, Breast surgery, Breast MRI, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Other | 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 Receives: Other: Skin and thickness measurement/breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (9)
Age in years
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Body Mass Index in kilogram per square meter
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Bra cup size
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Time in the menstrual cycle
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Contraception
Presence and type of contraception. Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Menopausal status
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
History of breast radiotherapy
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Breastfeeding history
Breastfeeding history after their potential pregnancies. Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
History of breast surgery
Evaluate the potential predictive factors of the biomechanical characteristics of the skin.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start31 Mar 2022
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha DURAES, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301998
- Sponsor's protocol ID
- RECHMPL21_0525
- Other IDs
- 2021-A02539-32
- Acronym
- SENO 3D
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han L, Hipwell JH, Eiben B, Barratt D, Modat M, Ourselin S, Hawkes DJ. A nonlinear biomechanical model based registration method for aligning prone and supine MR breast images. IEEE Trans Med Imaging. 2014 Mar;33(3):682-94. doi: 10.1109/TMI.2013.2294539.
PubMed 24595342Han L, Hipwell JH, Tanner C, Taylor Z, Mertzanidou T, Cardoso J, Ourselin S, Hawkes DJ. Development of patient-specific biomechanical models for predicting large breast deformation. Phys Med Biol. 2012 Jan 21;57(2):455-72. doi: 10.1088/0031-9155/57/2/455. Epub 2011 Dec 15.
PubMed 22173131Gefen A, Dilmoney B. Mechanics of the normal woman's breast. Technol Health Care. 2007;15(4):259-71.
PubMed 17673835Escoffier C, de Rigal J, Rochefort A, Vasselet R, Leveque JL, Agache PG. Age-related mechanical properties of human skin: an in vivo study. J Invest Dermatol. 1989 Sep;93(3):353-7.
PubMed 2768836Krueger N, Luebberding S, Oltmer M, Streker M, Kerscher M. Age-related changes in skin mechanical properties: a quantitative evaluation of 120 female subjects. Skin Res Technol. 2011 May;17(2):141-8. doi: 10.1111/j.1600-0846.2010.00486.x. Epub 2011 Feb 1.
PubMed 21281361Kim E, Cho G, Won NG, Cho J. Age-related changes in skin bio-mechanical properties: the neck skin compared with the cheek and forearm skin in Korean females. Skin Res Technol. 2013 Aug;19(3):236-41. doi: 10.1111/srt.12020. Epub 2013 Feb 26.
PubMed 23441628Ryu HS, Joo YH, Kim SO, Park KC, Youn SW. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res Technol. 2008 Aug;14(3):354-8. doi: 10.1111/j.1600-0846.2008.00302.x.
PubMed 19159383Diridollou S, Vabre V, Berson M, Vaillant L, Black D, Lagarde JM, Gregoire JM, Gall Y, Patat F. Skin ageing: changes of physical properties of human skin in vivo. Int J Cosmet Sci. 2001 Dec;23(6):353-62. doi: 10.1046/j.0412-5463.2001.00105.x.
PubMed 18498486Diridollou S, Black D, Lagarde JM, Gall Y, Berson M, Vabre V, Patat F, Vaillant L. Sex- and site-dependent variations in the thickness and mechanical properties of human skin in vivo. Int J Cosmet Sci. 2000 Dec;22(6):421-35.
PubMed 18503429Diridollou S, Patat F, Gens F, Vaillant L, Black D, Lagarde JM, Gall Y, Berson M. In vivo model of the mechanical properties of the human skin under suction. Skin Res Technol. 2000 Nov;6(4):214-221. doi: 10.1034/j.1600-0846.2000.006004214.x.
PubMed 11428960Hendriks FM, Brokken D, van Eemeren JT, Oomens CW, Baaijens FP, Horsten JB. A numerical-experimental method to characterize the non-linear mechanical behaviour of human skin. Skin Res Technol. 2003 Aug;9(3):274-83. doi: 10.1034/j.1600-0846.2003.00019.x.
PubMed 12877691Kappert KDR, Connesson N, Elahi SA, Boonstra S, Balm AJM, van der Heijden F, Payan Y. In-vivo tongue stiffness measured by aspiration: Resting vs general anesthesia. J Biomech. 2021 Jan 4;114:110147. doi: 10.1016/j.jbiomech.2020.110147. Epub 2020 Nov 25.
PubMed 33276256Schneider DC, Davidson TM, Nahum AM. In vitro biaxial stress-strain response of human skin. Arch Otolaryngol. 1984 May;110(5):329-33. doi: 10.1001/archotol.1984.00800310053012.
PubMed 6712522Kvistedal YA, Nielsen PM. Estimating material parameters of human skin in vivo. Biomech Model Mechanobiol. 2009 Feb;8(1):1-8. doi: 10.1007/s10237-007-0112-z. Epub 2007 Nov 27.
PubMed 18040732Reihsner R, Balogh B, Menzel EJ. Two-dimensional elastic properties of human skin in terms of an incremental model at the in vivo configuration. Med Eng Phys. 1995 Jun;17(4):304-13. doi: 10.1016/1350-4533(95)90856-7.
PubMed 7633759
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tridimensional Geometric Modeling of the Breast. Interest in Creating a Generic Biomechanical Model Useful for Simulation and Surgical Prediction
- ClinicalTrials.gov ID
- NCT05301998
- Acronym / sponsor ID
- SENO 3D / RECHMPL21_0525
- Conditions
- Breast Cancer, Skin Elasticity
- Keywords
- 3D geometric model, Breast surgery, Breast MRI, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Other | Other: Skin and thickness measurement/breast MRIMeasurements 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Up to 18 years old
- Understanding and acceptance of the protocol
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin and thickness measurement/breast MRIPatient 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 | Other | Study Group |
Primary outcome
Measurement of skin elasticity using a cutometer
Time frame: At baseline
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.
Measurement of skin thickness using an ultrasound device
Time frame: At baseline
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).
Collagen architecture of the breast
Time frame: 3 weeks after baseline
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).
3D model
Time frame: Through study completion, an average of 1 year
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
9 secondary outcomes
Age in years
Time frame: At baseline
Body Mass Index in kilogram per square meter
Time frame: At baseline
Bra cup size
Time frame: At baseline
Time in the menstrual cycle
Time frame: At baseline
Contraception
Time frame: At baseline
Menopausal status
Time frame: At baseline
History of breast radiotherapy
Time frame: At baseline
Breastfeeding history
Time frame: At baseline
History of breast surgery
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 24595342Han L, Hipwell JH, Eiben B, Barratt D, Modat M, Ourselin S, Hawkes DJ. A nonlinear biomechanical model based registration method for aligning prone and supine MR breast images. IEEE Trans Med Imaging. 2014 Mar;33(3):682-94. doi: 10.1109/TMI.2013.2294539.
- Background: PubMed 22173131Han L, Hipwell JH, Tanner C, Taylor Z, Mertzanidou T, Cardoso J, Ourselin S, Hawkes DJ. Development of patient-specific biomechanical models for predicting large breast deformation. Phys Med Biol. 2012 Jan 21;57(2):455-72. doi: 10.1088/0031-9155/57/2/455. Epub 2011 Dec 15.
- Background: PubMed 17673835Gefen A, Dilmoney B. Mechanics of the normal woman's breast. Technol Health Care. 2007;15(4):259-71.
- Background: PubMed 2768836Escoffier C, de Rigal J, Rochefort A, Vasselet R, Leveque JL, Agache PG. Age-related mechanical properties of human skin: an in vivo study. J Invest Dermatol. 1989 Sep;93(3):353-7.
- Background: PubMed 21281361Krueger N, Luebberding S, Oltmer M, Streker M, Kerscher M. Age-related changes in skin mechanical properties: a quantitative evaluation of 120 female subjects. Skin Res Technol. 2011 May;17(2):141-8. doi: 10.1111/j.1600-0846.2010.00486.x. Epub 2011 Feb 1.
- Background: PubMed 23441628Kim E, Cho G, Won NG, Cho J. Age-related changes in skin bio-mechanical properties: the neck skin compared with the cheek and forearm skin in Korean females. Skin Res Technol. 2013 Aug;19(3):236-41. doi: 10.1111/srt.12020. Epub 2013 Feb 26.
- Background: PubMed 19159383Ryu HS, Joo YH, Kim SO, Park KC, Youn SW. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res Technol. 2008 Aug;14(3):354-8. doi: 10.1111/j.1600-0846.2008.00302.x.
- Background: PubMed 18498486Diridollou S, Vabre V, Berson M, Vaillant L, Black D, Lagarde JM, Gregoire JM, Gall Y, Patat F. Skin ageing: changes of physical properties of human skin in vivo. Int J Cosmet Sci. 2001 Dec;23(6):353-62. doi: 10.1046/j.0412-5463.2001.00105.x.
- Background: PubMed 18503429Diridollou S, Black D, Lagarde JM, Gall Y, Berson M, Vabre V, Patat F, Vaillant L. Sex- and site-dependent variations in the thickness and mechanical properties of human skin in vivo. Int J Cosmet Sci. 2000 Dec;22(6):421-35.
- Background: PubMed 11428960Diridollou S, Patat F, Gens F, Vaillant L, Black D, Lagarde JM, Gall Y, Berson M. In vivo model of the mechanical properties of the human skin under suction. Skin Res Technol. 2000 Nov;6(4):214-221. doi: 10.1034/j.1600-0846.2000.006004214.x.
- Background: PubMed 12877691Hendriks FM, Brokken D, van Eemeren JT, Oomens CW, Baaijens FP, Horsten JB. A numerical-experimental method to characterize the non-linear mechanical behaviour of human skin. Skin Res Technol. 2003 Aug;9(3):274-83. doi: 10.1034/j.1600-0846.2003.00019.x.
- Background: PubMed 33276256Kappert KDR, Connesson N, Elahi SA, Boonstra S, Balm AJM, van der Heijden F, Payan Y. In-vivo tongue stiffness measured by aspiration: Resting vs general anesthesia. J Biomech. 2021 Jan 4;114:110147. doi: 10.1016/j.jbiomech.2020.110147. Epub 2020 Nov 25.
- Suction Chamber Methods for Measurement of Skin Mechanics : The New Digital Version of the Cutometer.Link provided by the sponsor.
- In-Vivo Soft Tissues Mechanical Characterization: Volume-Based Aspiration Method Validated on SiliconesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha DURAES, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin and thickness measurement/breast MRI in people with Breast Cancer and Skin Elasticity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of skin elasticity using a cutometer (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301998, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.