Assessing bone strength in patients with metastatic cancer using CT scans
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study
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 |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | denosumab, chemotherapy, immunotherapy |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT04170634 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 11 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.