Ireland
--:--IST
Recruiting Observational

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

NCT06774729 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-03
Last updated
2025-01-14

Condition(s) studied

Soft Tissue Sarcoma (STS)Bone Cancer Tumor

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774729 on ClinicalTrials.gov ↗ ← All trials in Italy