Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
MEKANOS
1 other identifier
observational
220
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedStudy Start
First participant enrolled
November 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 28, 2026
December 16, 2024
December 1, 2024
7 years
November 18, 2019
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of mechanical strength of tumor proximal femur or tumor vertebrae obtained by numerical simulation using the finite element analysis (FEA) method.
Measurement of mechanical strength (expressed in Newton : N), monopodal support at the upper end of the femur and uniaxial compression on the vertebrae, obtained by numerical simulation using the finite element analysis (FEA) method. As an indication, the average resistance of a femur of an elderly patient in monopod support is on average 9000 N and that of the L3 vertebra in uniaxial compression is on average 2700 N. Comparative values will also be obtained on the healthy contralateral femur and an adjacent healthy vertebra of each patient
24 months
Study Arms (1)
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.
Interventions
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
Adult patients with predominantly osteolytic tumor involvement related either to myeloma or bone metastases of lung, breast, bladder, thyroid or kidney cancer.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Service de rhumatologie, CHU d'Angers
Angers, 49100, France
Ch Annecy Genevois
Annecy, 74000, France
Service de radiothérapie, Institut Jean-Perrin
Clermont-Ferrand, 63011, France
Service de rhumatologie, CH Annemasse
Contamine-sur-Arve, 74130, France
Service d'onco-rhumatologie, Centre Oscar Lombret
Lille, 59000, France
Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian
Lyon, 69008, France
Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm
Paris, 75014, France
Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris
Paris, 75014, France
Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
Service de rhumatologie, CHU de Poitiers
Poitiers, 86021, France
Service de rhumatologie, CHU de Saint Etienne
Saint-Priest-en-Jarez, 42270, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
Biospecimen
Blood collection: 12 mL of blood (4 mL for plasma and 8 mL for serum isolation) will be collected at the baseline, concomitantly to routine blood analysis. Plasma and serum will be stored at -80°C for further analysis on bone markers (CTX: C-Terminal Telopeptide, DKK1: Dickkopf-1, ALP: Alkaline Phosphatase and P1NP: Procollagen I N-Terminal Propeptide). Ancillary study: The ancillary study will allow the experimental characterization of the mechanical properties of the bone and soft tissue tumor volume, in order to integrate them into the simulation and conduct a sensitivity study for a wide range of values
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cyrille CONFAVREUX, PR
Service de Rhumatologie
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2019
First Posted
November 20, 2019
Study Start
November 28, 2019
Primary Completion (Estimated)
November 28, 2026
Study Completion (Estimated)
November 28, 2026
Last Updated
December 16, 2024
Record last verified: 2024-12