RecruitingNCT04170634

Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study

Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study


Sponsor

Hospices Civils de Lyon

Enrollment

220 participants

Start Date

Nov 28, 2019

Study Type

OBSERVATIONAL

Conditions

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. 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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using computer simulations based on CT scan images to assess the structural strength of bones that have been weakened by cancer that has spread (metastasized) from other parts of the body. The goal is to better predict fracture risk without additional invasive procedures. **You may be eligible if...** - You are an adult (over 18) - You have bone metastases from breast cancer, non-small cell lung cancer, kidney cancer, bladder cancer, thyroid cancer, or myeloma - You have had or will have a CT scan of the affected bone area within a 30-day window **You may NOT be eligible if...** - You have a primary bone cancer (not metastatic) - No relevant CT scan is available within the required timeframe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREvaluation 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).


Locations(12)

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

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NCT04170634


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