Metastases to BoneMEKANOSNCT04170634
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
An observational study of Metastases to Bone and Metastatic Breast Cancer, run by Hospices Civils de Lyon at 12 sites in France.
Trial summary
Osteolytic bone metastases and myeloma bone lesions are responsible of long bone and vertebral fractures leading to restricted mobility, surgery and medullar compression that severely alter quality of life and that have a huge medico-economic impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases to Bone, Metastatic Breast Cancer, Metastatic NSCLC
- What is being tested?
- Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation
- How many people
- 220 participants
- Where
- 12 sitesFrance
- Study dates
- 28 Nov 2019to 28 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with predominantly osteolytic tumor involvement related either to myeloma or bone metastases of lung, breast, bladder, thyroid or kidney cancer.
Who may be able to join
- Adult patients (> 18 years of age).
- Patients who do not object to participating in the study. For patients participating to the biological collection: signature of the written informed consent..
- Patients with secondary tumor lesion(s) of mammary or pulmonary non-small cell, renal, bladder, thyroid or myeloma bone origin.
- Existence of a CT scan focused on the target lesion (or which will be performed as part of the care), performed within a time window of 30 days before and 20 days after inclusion, as part of the patient's usual bone management.
- Target location: upper end of the femur (1/3 proximal) and/or vertebrae. Several locations are possible for the same patient, provided that the inclusion criteria are met for each target.
- Size of target lesion: either diffuse permeative or > 15 mm in size.
- Exposure to systemic bone therapy for 3 months or less (daily clodronate or denosumab, zoledronic acid, monthly pamidronate) is allowed
- Patients who received previous systemic oncological treatments (chemotherapy, targeted therapy, immunotherapy…) are eligible.
Who cannot join
- Patients who have received targeted treatment at the target location either in the form of radiotherapy, surgery or interventional radiology (cementoplasty, cryotherapy, radiofrequency).
- Fractured pathological target bone.
- For the femur target, the patient must not have a hip prosthesis on either side (target or contralateral)
- Patients under trusteeship.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
Service de rhumatologie, CHU d'Angers
Angers, 49100
Béatrice BOUVARD, 2 41 35 35 76 ext. +33, bebouvard@chu-angers.fr
- Recruiting
Ch Annecy Genevois
Annecy, 74000
Frédérique ORSINI-PIOCELLE, 0450636144, forsinipiocelle@ch-annecy-genevois.fr
- Recruiting
Service de radiothérapie, Institut Jean-Perrin
Clermont-Ferrand, 63011
Aurélie BELLIERE, 4 73 27 81 42 ext. +33, aurelie.belliere@laposte.net
- Recruiting
Service de rhumatologie, CH Annemasse
Contamine-sur-Arve, 74130
Arnaud MAZOUYES, 4 50 82 29 81 ext. +33, amazouyes@ch-alpes-léman.fr
- Recruiting
Service d'onco-rhumatologie, Centre Oscar Lombret
Lille, 59000
Marie-Hélène VIEILLARD, 3 20 44 40 58 ext. +33, mh-vieillard@chru-lille.fr
- Recruiting
Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian
Lyon, 69008
Line CLAUDE, 4 78 78 26 49 ext. +33, line.claude@lyon.unicancer.fr
- Recruiting
Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm
Paris, 75014
Nicolas GIRARD, 1 56 61 62 50 ext. +33, nicolas.girard2@curie.fr
- Recruiting
Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris
Paris, 75014
Antoine FEYDY, 1 58 41 24 83 ext. +33, antoine.feydy@aphp.fr
- Recruiting
Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud
Pierre-Bénite, 69310
Cyrille CONFAVREUX, PR, 4 78 86 12 31 ext. +33, Cyrille.confavreux@chu-lyon.fr
- Recruiting
Service de rhumatologie, CHU de Poitiers
Poitiers, 86021
Guillaumd LARID, 05 49 44 44 65 ext. +33, guillaume.larid@chu-poitiers.fr
- Recruiting
Service de rhumatologie, CHU de Saint Etienne
Saint-Priest-en-Jarez, 42270
Thierry THOMAS, 4 77 12 76 42 ext. +33
Karima BOUSSOUALI, 4 77 12 76 42 ext. +33, Karima.boussoualim@chu-st-etienne.fr
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500
Selima SELLAMI, 03 83 59 84 00, s.sellami@nancy.unicancer.fr
About this study
Official title: Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study
Osteolytic bone metastases and myeloma bone lesions are responsible of long bone and vertebral fractures leading to restricted mobility, surgery and medullar compression that severely alter quality of life and that have a huge medico-economic impact. It has been estimated that 50% of the patients with bone metastasis will encounter bone complications. In the recent years, Bone Oncology Multidisciplinary Meetings have been developed to optimize bone metastases management for each patient in harmony with oncology program.
The assessment of the fracture risk of bone metastasis remains fairly empirical and is based on simple radiography. The Mirel's score for long bones is focused on the extent of cortical defect caused by bone metastasis to identify high-risk patients at risk of fracture during surgery. It is old, little used in routine and lacks sensitivity and specificity. The SINS (Spinal Instability Neoplastic Score) score is the reference for vertebrae. Today, most patients with fracture-risk bone metastasis benefit from a lesion-centered CT scan to better characterize its extent and position but the interpretation remains qualitative. Metastases are considered as an air cavity and the mechanical properties of the tumor are not evaluated. However, many other parameters from the CTscan are available such as cortical or trabecular compartment densitometry, cortical thickness, tumor volume, and position of lysis in the bone.
Read more
Based on experience acquired by the service in the evaluation of bone mechanical strength on benign bones, the investigator aim at integrating in the numerical simulation the mechanical properties of both bone and tumor, in order to evaluate the mechanical strength of the pathological bone using a numerical simulation model (finite element analysis-FEA).
MEKANOS will enroll patients with bone metastases of breast, lung, kidney, thyroid or bladder cancer and myeloma lesions affecting the vertebrae or the upper end of the femur.
The resistance obtained will be compared to that of an intact bone. The best predictive parameters of mechanical strength (position of lysis, tumor nature, and bone architecture) will be then determined. Finally, the added value of this technique in relation to historical fragility scores (Mirel's and SINS scores) will be assessed.
The ultimate goal is to provide tools to assess fracture risk and improve the preventive management of bone metastases in harmony with the referring oncologist
- Being tested
- Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation
- Keywords
- osteolytic secondary tumoral lesion, femur, vertebrae, qCT routine imagery
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulationOther
Assessment of the mechanical tumor bone strength by numerical simulation using qCT routine imagery of proximal femur (applying a monopodal standing load) and vertebrae (applying a uniaxial compression load).
| Study group | Role | What they receive |
|---|---|---|
| Patients with bone metastases at risk of fracture | Adult patients with tumor osteolytic bone lesions located in proximal femur and/or vertebrae secondary to a myeloma or a breast, lung (NSCL: Non-Small Cell Lung), bladder, thyroid or kidney cancer. The target vertebrae or femur has to be naïve of localized treatment (interventional radiology - cementoplasty, cryotherapy, radiofrequency…). Previous exposure to systemic oncological treatments (chemotherapy, targeted therapy, immunotherapy…) and bone treatments are allowed if administered for less than 3 months. Receives: Other: Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of mechanical strength of tumor proximal femur or tumor vertebrae obtained by numerical simulation using the finite element analysis (FEA) method.
Measurement of mechanical strength (expressed in Newton : N), monopodal support at the upper end of the femur and uniaxial compression on the vertebrae, obtained by numerical simulation using the finite element analysis (FEA) method.
As an indication, the average resistance of a femur of an elderly patient in monopod support is on average 9000 N and that of the L3 vertebra in uniaxial compression is on average 2700 N.
Comparative values will also be obtained on the healthy contralateral femur and an adjacent healthy vertebra of each patient
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start28 Nov 2019
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastases to BoneStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrille CONFAVREUX, PR, Principal investigator, Service de Rhumatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170634
- Sponsor's protocol ID
- 69HCL17_0642
- Acronym
- MEKANOS
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2019
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study
- ClinicalTrials.gov ID
- NCT04170634
- Acronym / sponsor ID
- MEKANOS / 69HCL17_0642
- Keywords
- osteolytic secondary tumoral lesion, femur, vertebrae, qCT routine imagery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 20 Nov 2019 (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.
Osteolytic bone metastases and myeloma bone lesions are responsible of long bone and vertebral fractures leading to restricted mobility, surgery and medullar compression that severely alter quality of life and that have a huge medico-economic impact. It has been estimated that 50% of the patients with bone metastasis will encounter bone complications. In the recent years, Bone Oncology Multidisciplinary Meetings have been developed to optimize bone metastases management for each patient in harmony with oncology program.
The assessment of the fracture risk of bone metastasis remains fairly empirical and is based on simple radiography. The Mirel's score for long bones is focused on the extent of cortical defect caused by bone metastasis to identify high-risk patients at risk of fracture during surgery. It is old, little used in routine and lacks sensitivity and specificity. The SINS (Spinal Instability Neoplastic Score) score is the reference for vertebrae. Today, most patients with fracture-risk bone metastasis benefit from a lesion-centered CT scan to better characterize its extent and position but the interpretation remains qualitative. Metastases are considered as an air cavity and the mechanical properties of the tumor are not evaluated. However, many other parameters from the CTscan are available such as cortical or trabecular compartment densitometry, cortical thickness, tumor volume, and position of lysis in the bone.
Based on experience acquired by the service in the evaluation of bone mechanical strength on benign bones, the investigator aim at integrating in the numerical simulation the mechanical properties of both bone and tumor, in order to evaluate the mechanical strength of the pathological bone using a numerical simulation model (finite element analysis-FEA).
MEKANOS will enroll patients with bone metastases of breast, lung, kidney, thyroid or bladder cancer and myeloma lesions affecting the vertebrae or the upper end of the femur.
The resistance obtained will be compared to that of an intact bone. The best predictive parameters of mechanical strength (position of lysis, tumor nature, and bone architecture) will be then determined. Finally, the added value of this technique in relation to historical fragility scores (Mirel's and SINS scores) will be assessed.
The ultimate goal is to provide tools to assess fracture risk and improve the preventive management of bone metastases in harmony with the referring oncologist
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bone metastases at risk of fracture | – | Other: Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulationAdult patients with tumor osteolytic bone lesions located in proximal femur and/or vertebrae secondary to a myeloma or a breast, lung (NSCL: Non-Small Cell Lung), bladder, thyroid or kidney cancer. The target vertebrae or femur has to be naïve of localized treatment (interventional radiology - cementoplasty, cryotherapy, radiofrequency…). Previous exposure to systemic oncological treatments (chemotherapy, targeted therapy, immunotherapy…) and bone treatments are allowed if administered for less than 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with predominantly osteolytic tumor involvement related either to myeloma or bone metastases of lung, breast, bladder, thyroid or kidney cancer.
Key inclusion criteria (8 listed)
- Adult patients (> 18 years of age).
- Patients who do not object to participating in the study. For patients participating to the biological collection: signature of the written informed consent..
- Patients with secondary tumor lesion(s) of mammary or pulmonary non-small cell, renal, bladder, thyroid or myeloma bone origin.
- Existence of a CT scan focused on the target lesion (or which will be performed as part of the care), performed within a time window of 30 days before and 20 days after inclusion, as part of the patient's usual bone management.
- Target location: upper end of the femur (1/3 proximal) and/or vertebrae. Several locations are possible for the same patient, provided that the inclusion criteria are met for each target.
Key exclusion criteria (4 listed)
- Patients who have received targeted treatment at the target location either in the form of radiotherapy, surgery or interventional radiology (cementoplasty, cryotherapy, radiofrequency).
- Fractured pathological target bone.
- For the femur target, the patient must not have a hip prosthesis on either side (target or contralateral)
- Patients under trusteeship.
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 |
|---|---|---|
| Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulationAssessment of the mechanical tumor bone strength by numerical simulation using qCT routine imagery of proximal femur (applying a monopodal standing load) and vertebrae (applying a uniaxial compression load). | Other | Patients with bone metastases at risk of fracture |
Primary outcome
Measurement of mechanical strength of tumor proximal femur or tumor vertebrae obtained by numerical simulation using the finite element analysis (FEA) method.
Time frame: 24 months
Measurement of mechanical strength (expressed in Newton : N), monopodal support at the upper end of the femur and uniaxial compression on the vertebrae, obtained by numerical simulation using the finite element analysis (FEA) method. As an indication, the average resistance of a femur of an elderly patient in monopod support is on average 9000 N and that of the L3 vertebra in uniaxial compression is on average 2700 N. Comparative values will also be obtained on the healthy contralateral femur and an adjacent healthy vertebra of each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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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.
Cyrille CONFAVREUX, PR principal investigator
Service de Rhumatologie
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastases to Bone and Metastatic Breast Cancer, run by Hospices Civils de Lyon at 12 sites 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrille CONFAVREUX, PR (4.78.86.12.31 ext. +33, cyrille.confavreux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of mechanical strength of tumor proximal femur or tumor vertebrae obtained by numerical simulation using the finite element analysis (FEA) method. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.