NCT04170634Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 18 Nov 2019
- Start date
- 28 Nov 2019
- Primary completion date
- 28 Nov 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Lung cancer, Metastatic breast cancer
- NCT number
- NCT04170634
What you commit to
- Study type: Observational
- Planned participants: 220
- From 28 Nov 2019 to the primary completion date, 28 Nov 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received targeted treatment at the target location either in the form of radiotherapy, surgery or interventional radiology (cementoplasty, cryotherapy, radiofrequency).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de rhumatologie, CHU d'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Ch Annecy Genevois Coordinator of this site? Confirm its status | Annecy | France | Recruiting |
| Service de radiothérapie, Institut Jean-Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Service de rhumatologie, CH Annemasse Coordinator of this site? Confirm its status | Contamine-sur-Arve | France | Recruiting |
| Service d'onco-rhumatologie, Centre Oscar Lombret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Service de rhumatologie, CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Service de rhumatologie, CHU de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.