Actively Recruiting
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study
Led by Hospices Civils de Lyon · Updated on 2024-12-16
220
Participants Needed
12
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating osteolytic bone metastases and myeloma bone lesions that cause fractures in long bones and vertebrae, leading to limited mobility, surgery, and spinal cord compression. These complications greatly affect quality of life and have significant medical and economic consequences. The study aims to improve fracture risk assessment, which is currently based on simple X-rays and scores like Mirel's and SINS, by using quantitative CT scans and advanced numerical simulation techniques to better evaluate the mechanical strength of bones affected by tumors. This observational study enrolls adult patients with bone metastases or myeloma lesions in the upper femur or vertebrae from cancers such as breast, lung, kidney, thyroid, or bladder. Participants undergo quantitative CT scans of the affected bone areas. The mechanical strength of the tumor-affected bone is assessed using finite element analysis (FEA), a numerical simulation method that accounts for bone and tumor properties. This approach is compared to traditional fracture risk scores to determine its added value. Participants provide informed consent and have a CT scan performed within 30 days before or 20 days after study inclusion, as part of their usual care. Researchers collect data on bone and tumor characteristics to predict fracture risk and improve management strategies. The primary outcome is the mechanical strength measurement of the tumor-affected femur or vertebrae over 24 months. The study supports better prevention of fractures in patients with bone metastases while coordinating with their oncology treatment.
CONDITIONS
Brief 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 older than 18 years
- Patients willing to participate and provide informed consent if applicable
- Patients with secondary tumor lesions from breast, lung (non-small cell), kidney, bladder, thyroid cancers or myeloma
- Availability of a CT scan focused on the target lesion performed 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 is either diffuse permeative or larger than 15 mm
- Exposure to systemic bone treatments for 3 months or less is allowed
- Previous systemic oncological treatments are allowed
You will not qualify if you...
- Previous localized treatment (radiotherapy, surgery, interventional radiology) to the target bone area
- Pathological fracture of the target bone
- Presence of a hip prosthesis on either side if the target lesion is in the femur
- Patients under legal trusteeship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 50 days around inclusion
Participants undergo quantitative CT scans of the target bone lesions as part of routine care to assess tumor bone strength using numerical simulation.
1 scan visit (routine care)
Duration - 24 months
Participants are observed to measure mechanical strength of tumor bone lesions over 24 months using numerical simulation data.
Assessments occur based on available imaging and simulations
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
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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
S
Sara CALATTINI
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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