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

NCT ID: NCT06774729

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2028-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Sarcoma (STS) Bone Cancer Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vincenzo Lucidi, MD

Role: CONTACT

+39 3385246923

Facility Contacts

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Vincenzo Lucidi, MD

Role: primary

+39 3385246923

Other Identifiers

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MIT3

Identifier Type: -

Identifier Source: org_study_id

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