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

January 9, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists in participants with a suspect of soft tissue sarcoma or bone cancer that are followed at Radiology Department of IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value (PPV)
Time Frame: 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).
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
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).
From enrollment to the end of treatment at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIT3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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