Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
NCT ID: NCT04170634
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
220 participants
OBSERVATIONAL
2019-11-28
2026-11-28
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation
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).
Interventions
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Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation
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).
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Cyrille CONFAVREUX, PR
Role: PRINCIPAL_INVESTIGATOR
Service de Rhumatologie
Locations
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Service de rhumatologie, CHU d'Angers
Angers, , France
Ch Annecy Genevois
Annecy, , France
Service de radiothérapie, Institut Jean-Perrin
Clermont-Ferrand, , France
Service de rhumatologie, CH Annemasse
Contamine-sur-Arve, , France
Service d'onco-rhumatologie, Centre Oscar Lombret
Lille, , France
Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian
Lyon, , France
Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm
Paris, , France
Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris
Paris, , France
Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud
Pierre-Bénite, , France
Service de rhumatologie, CHU de Poitiers
Poitiers, , France
Service de rhumatologie, CHU de Saint Etienne
Saint-Priest-en-Jarez, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Béatrice BOUVARD
Role: primary
Frédérique ORSINI-PIOCELLE
Role: primary
Aurélie BELLIERE
Role: primary
Arnaud MAZOUYES
Role: primary
Marie-Hélène VIEILLARD
Role: primary
Line CLAUDE
Role: primary
Nicolas GIRARD
Role: primary
Antoine FEYDY
Role: primary
Cyrille CONFAVREUX, PR
Role: primary
Guillaumd LARID
Role: primary
Thierry THOMAS
Role: primary
Karima BOUSSOUALI
Role: backup
Selima SELLAMI
Role: primary
Other Identifiers
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69HCL17_0642
Identifier Type: -
Identifier Source: org_study_id