Informations générales (source: ClinicalTrials.gov)
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study (MEKANOS)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
novembre 2019
novembre 2026
11 octobre 2024
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GPE HOSP COCHIN SAINT VINCENT DE PAUL | Antoine FEYDY | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service de radiothérapie, Institut Jean-Perrin - 63011 - Clermont-Ferrand - France | Aurélie BELLIERE | Contact (sur clinicalTrials) | |||
| Service de rhumatologie, CH Annemasse - 74130 - Contamine-sur-Arve - France | Arnaud MAZOUYES | Contact (sur clinicalTrials) | |||
| Service de rhumatologie, CHU d'Angers - 49100 - Angers - France | Béatrice BOUVARD | Contact (sur clinicalTrials) | |||
| Service de rhumatologie, CHU de Poitiers - 86021 - Poitiers - France | Françoise DEBIAIS | Contact (sur clinicalTrials) | |||
| Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud - 69310 - Pierre-Bénite - France | Cyrille CONFAVREUX, PR | Contact (sur clinicalTrials) | |||
| Service d'onco-rhumatologie, Centre Oscar Lombret - 59000 - Lille - France | Marie-Hélène VIEILLARD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian - 69008 - Lyon - France | Line CLAUDE | Contact (sur clinicalTrials) | |||
| Service de rhumatologie, CHU de Grenoble - 38700 - La Tronche - France | Athan BAILLET | Contact (sur clinicalTrials) | |||
| Service de rhumatologie, CHU de Saint Etienne - 42270 - Saint-Priest-en-Jarez - France | Thierry THOMAS | Contact (sur clinicalTrials) | |||
| Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm - 75014 - Paris - France | Nicolas GIRARD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- 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.