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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06774729

Enrollment

122

Registered

2025-01-14

Start date

2025-03-31

Completion date

2028-10-31

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Cancer Tumor, Soft Tissue Sarcoma (STS)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Italy

Contacts

Primary ContactVincenzo Lucidi, MD

vincenzo.lucidi@aosp.bo.it+39 3385246923

Outcome results