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

Recruitingn/aAges 18 Years - anyAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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 (Spin

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📋 Eligibility rules (as published)
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. Exclusion Criteria: * 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.
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What it tests

  • Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation
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Where

12 sites
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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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