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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04170634
Other study ID # 69HCL17_0642
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 28, 2019
Est. completion date November 28, 2026

Study information

Verified date September 2023
Source Hospices Civils de Lyon
Contact Cyrille CONFAVREUX, PR
Phone 4.78.86.12.31
Email cyrille.confavreux@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date November 28, 2026
Est. primary completion date November 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation
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).

Locations

Country Name City State
France Service de rhumatologie, CHU d'Angers Angers
France Service de radiothérapie, Institut Jean-Perrin Clermont-Ferrand
France Service de rhumatologie, CH Annemasse Contamine-sur-Arve
France Service de rhumatologie, CHU de Grenoble La Tronche
France Service d'onco-rhumatologie, Centre Oscar Lombret Lille
France Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian Lyon
France Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm Paris
France Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris Paris
France Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud Pierre-Bénite
France Service de rhumatologie, CHU de Poitiers Poitiers
France Service de rhumatologie, CHU de Saint Etienne Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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