Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor

Recruiting

• Conditions: Soft Tissue Sarcoma (STS); Bone Cancer Tumor

• Registration Number: NCT06774729
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-03
• Primary Completion: 2028-09
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV)	From enrollment to the end of treatment at 2 years	It is the ratio of patients truly diagnosed as positive to all those who had positive test results (including healthy subjects who were incorrectly diagnosed as patient).
Negative Predictive Value (NPV)	From enrollment to the end of treatment at 2 years	It is the ratio of subjects truly diagnosed as negative to all those who had negative test results (including patients who were incorrectly diagnosed as healthy).

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy