Assessing bone strength in patients with metastatic cancer using CT scans
Official title: Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study
Run by Hospices Civils de Lyon · NCT04170634 · Data updated 2026-11-12
This study is testing if special CT scans can help doctors better understand the risk of fractures in patients with bone cancer from breast cancer or lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | denosumab, chemotherapy, immunotherapy |
| Locations | 12 sites (Angers and 11 other locations) |
| Status | Recruiting |
| Started | November 28, 2019 |
| Main results expected | November 28, 2026 |
| Study ends | November 28, 2026 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT04170634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with secondary bone lesions from specific cancers, such as breast or lung cancer, who have recent CT scans of the affected areas.
✕Probably not a fit
Patients without secondary bone lesions or those whose CT scans do not meet the study criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the fracture risk in patients with osteolytic bone metastases through quantitative CT (qCT) scans and numerical simulations. It focuses on patients with metastatic breast cancer and non-small cell lung cancer, utilizing routine imaging data to improve the assessment of bone integrity. The study seeks to enhance current methods, which are often empirical and lack sensitivity, by providing a more accurate evaluation of fracture risk. By integrating advanced imaging techniques, the study aims to optimize patient management and treatment strategies.
Why it matters
Potential benefit: If successful, this study could lead to improved fracture risk assessments, enhancing patient care and quality of life for those with bone metastases.
How similar studies have gone: While there have been studies focusing on fracture risk in metastatic patients, this approach using qCT and numerical simulation is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Service de rhumatologie, CHU d'Angers
Angers, France Recruiting -
Ch Annecy Genevois
Annecy, France Recruiting -
Service de radiothérapie, Institut Jean-Perrin
Clermont-Ferrand, France Recruiting -
Service de rhumatologie, CH Annemasse
Contamine-sur-Arve, France Recruiting -
Service d'onco-rhumatologie, Centre Oscar Lombret
Lille, France Recruiting -
Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian
Lyon, France Recruiting
Show 6 more locations
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Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm
Paris, France Recruiting -
Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris
Paris, France Recruiting -
Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud
Pierre-Bénite, France Recruiting -
Service de rhumatologie, CHU de Poitiers
Poitiers, France Recruiting -
Service de rhumatologie, CHU de Saint Etienne
Saint-Priest-en-Jarez, France Recruiting -
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France Recruiting
Study contacts
- Principal investigator: Cyrille CONFAVREUX, PR — Service de Rhumatologie
- Study coordinator: Cyrille CONFAVREUX, PR
- Email: cyrille.confavreux@chu-lyon.fr
- Phone: 4.78.86.12.31
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.