Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma (STS), Bone Cancer Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a Radiomics Model With 3T Multiparametric MR to Predict the Occurence of a Perilesional Infiltration of Muscoskeletal Tumor During the Pre- Surgery Planning
Overview
The goal of this observational study is to evaluate the feasibility and clinical utility of radiomics to diagnose peri-lesion tumour infiltration of tumours in participants with a suspect of Bone Cancer Tumor or Soft Tissue Sarcoma (STS). The main questions it aims to answer are: * is radiomics able to identify the ratio of participants truly diagnosed as positive to all those who had positive test results? * is radiomics able to identify the likelihood that a participant who has a negative test result indeed does not have the disease? Participants eligible for this study will get a MRI as part of their regular medical care. The only difference is that their data will be recorded and anonymously analyzed.
Primary outcome measures
- Positive Predictive Value (PPV) [Time frame: From enrollment to the end of treatment at 2 years]
- Negative Predictive Value (NPV) [Time frame: From enrollment to the end of treatment at 2 years]
Eligibility criteria
Inclusion criteria
- Age over 18
- suspect of soft tissue sarcoma with a indication for surgical treatment
- suspect of bone cancer tumor with a indication for surgical treatment
- To give informed consent
Exclusion criteria
- simultaneous cancer or history of cancer in the last 5 years
- acute or chronic serious conditions that could
- contraindication to conduct a Contrast-enhanced magnetic resonance imaging (MRI) such as:
- renal failure without dialysis
- history of allergy to a paramagnetic contrast agent
- claustrophobia
- symptomatic epilepsy or history of epilepsy
- cardiac pacemaker
- infusion pump, prosthesis or any implant not compatible with MRI
- pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06774729 · MIT3