Actively Recruiting

Age: 18Years +
All Genders
ID04170634

Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study

Led by Hospices Civils de Lyon · Updated on 2024-12-16

220

Participants Needed

12

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating osteolytic bone metastases and myeloma bone lesions that cause fractures in long bones and vertebrae, leading to limited mobility, surgery, and spinal cord compression. These complications greatly affect quality of life and have significant medical and economic consequences. The study aims to improve fracture risk assessment, which is currently based on simple X-rays and scores like Mirel's and SINS, by using quantitative CT scans and advanced numerical simulation techniques to better evaluate the mechanical strength of bones affected by tumors. This observational study enrolls adult patients with bone metastases or myeloma lesions in the upper femur or vertebrae from cancers such as breast, lung, kidney, thyroid, or bladder. Participants undergo quantitative CT scans of the affected bone areas. The mechanical strength of the tumor-affected bone is assessed using finite element analysis (FEA), a numerical simulation method that accounts for bone and tumor properties. This approach is compared to traditional fracture risk scores to determine its added value. Participants provide informed consent and have a CT scan performed within 30 days before or 20 days after study inclusion, as part of their usual care. Researchers collect data on bone and tumor characteristics to predict fracture risk and improve management strategies. The primary outcome is the mechanical strength measurement of the tumor-affected femur or vertebrae over 24 months. The study supports better prevention of fractures in patients with bone metastases while coordinating with their oncology treatment.

CONDITIONS

Brief 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 older than 18 years
  • Patients willing to participate and provide informed consent if applicable
  • Patients with secondary tumor lesions from breast, lung (non-small cell), kidney, bladder, thyroid cancers or myeloma
  • Availability of a CT scan focused on the target lesion performed 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 is either diffuse permeative or larger than 15 mm
  • Exposure to systemic bone treatments for 3 months or less is allowed
  • Previous systemic oncological treatments are allowed
Not Eligible

You will not qualify if you...

  • Previous localized treatment (radiotherapy, surgery, interventional radiology) to the target bone area
  • Pathological fracture of the target bone
  • Presence of a hip prosthesis on either side if the target lesion is in the femur
  • Patients under legal trusteeship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 50 days around inclusion

Participants undergo quantitative CT scans of the target bone lesions as part of routine care to assess tumor bone strength using numerical simulation.

1 scan visit (routine care)

Long-term Monitoring

Duration - 24 months

Participants are observed to measure mechanical strength of tumor bone lesions over 24 months using numerical simulation data.

Assessments occur based on available imaging and simulations

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

S

Sara CALATTINI

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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