Actively Recruiting
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
Led by Hospices Civils de Lyon · Updated on 2024-12-16
220
Participants Needed
12
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (over 18 years old)
- Patients who agree to participate and provide informed consent if involved in biological collection
- Patients with secondary bone tumor lesions from breast, lung non-small cell, kidney, bladder, thyroid cancer, or myeloma
- Availability of a CT scan focused on the target lesion taken within 30 days before or 20 days after inclusion
- Target lesion located in the upper third of the femur and/or vertebrae
- Target lesion size larger than 15 mm or diffuse permeative
- Exposure to systemic bone therapy for 3 months or less is allowed
- Previous systemic oncological treatments like chemotherapy, targeted therapy, or immunotherapy are allowed
You will not qualify if you...
- Patients who received radiotherapy, surgery, or interventional radiology on the target bone
- Patients with fractured pathological target bone
- Patients with a hip prosthesis on either side if the target is the femur
- Patients under trusteeship
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Service de rhumatologie, CHU d'Angers
Angers, France, 49100
Actively Recruiting
2
Ch Annecy Genevois
Annecy, France, 74000
Actively Recruiting
3
Service de radiothérapie, Institut Jean-Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
4
Service de rhumatologie, CH Annemasse
Contamine-sur-Arve, France, 74130
Actively Recruiting
5
Service d'onco-rhumatologie, Centre Oscar Lombret
Lille, France, 59000
Actively Recruiting
6
Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian
Lyon, France, 69008
Actively Recruiting
7
Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm
Paris, France, 75014
Actively Recruiting
8
Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris
Paris, France, 75014
Actively Recruiting
9
Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
10
Service de rhumatologie, CHU de Poitiers
Poitiers, France, 86021
Actively Recruiting
11
Service de rhumatologie, CHU de Saint Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
12
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
C
Cyrille CONFAVREUX, PR
CONTACT
S
Sara CALATTINI
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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