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

NCT06774729 | Recruiting

• 1 other identifier: MIT3
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma (STS); Bone Cancer Tumor

Outcome Measures

Primary Outcomes (2)

• Positive Predictive Value (PPV)

  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)

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Vincenzo Lucidi, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)