Actively Recruiting

Age: 18Years +
All Genders
NCT04170634

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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