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

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.

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Key information

Conditions

Soft Tissue Sarcoma (STS) Bone Cancer Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Vincenzo Lucidi, MD

CONTACT

[email protected]

+39 3385246923

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).
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).

Study contacts

Contact information is provided by the study sponsor or research team.

Vincenzo Lucidi, MD

CONTACT

[email protected]

+39 3385246923

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jan 14, 2025
Registry last updated: Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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