Clinical trial NCT04170634: Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
Official title: Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastases to Bone
Metastatic Breast Cancer
Metastatic NSCLC
Keywords: osteolytic secondary tumoral lesion
femur
vertebrae
qCT routine imagery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with predominantly osteolytic tumor involvement related either to myeloma or bone metastases of lung, breast, bladder, thyroid or kidney cancer.

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Measurement of mechanical strength of tumor proximal femur or tumor vertebrae obtained by numerical simulation using the finite element analysis (FEA) method.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de rhumatologie, CHU d'Angers
city: Annecy
country: France
facility: Ch Annecy Genevois
city: Clermont-Ferrand
country: France
facility: Service de radiothérapie, Institut Jean-Perrin
city: Contamine-sur-Arve
country: France
facility: Service de rhumatologie, CH Annemasse
city: Lille
country: France
facility: Service d'onco-rhumatologie, Centre Oscar Lombret
city: Lyon
country: France
facility: Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian
city: Paris
country: France
facility: Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm
city: Paris
country: France
facility: Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris
city: Pierre-Bénite
country: France
facility: Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Service de rhumatologie, CHU de Poitiers
city: Saint-Priest-en-Jarez
country: France
facility: Service de rhumatologie, CHU de Saint Etienne
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Service de Rhumatologie
name: Cyrille CONFAVREUX, PR
role: PRINCIPAL_INVESTIGATOR
References: