Actively Recruiting
Development of a Radiomics Model With 3T Multiparametric MRI to Predict Perilesional Infiltration of Musculoskeletal Tumors Before Surgery
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-14
122
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to explore how well radiomics can diagnose the infiltration of tumors near lesions in people suspected of having Bone Cancer Tumors or Soft Tissue Sarcoma (STS). The study aims to find out if radiomics can accurately identify those truly diagnosed as positive among all positive test results and also determine the likelihood that a negative test result means the participant does not have the disease. Participants in this study will receive an MRI as part of their usual medical care. Their MRI data will be collected anonymously and analyzed to develop a radiomics model that might help predict tumor infiltration before surgery. There are no additional treatments or interventions beyond the standard MRI scan. During the study, which lasts up to two years from enrollment, researchers will evaluate the positive predictive value and negative predictive value of the radiomics approach. Participants' medical information will be reviewed securely and anonymously, with no extra procedures required. The study is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna and started in March 2025, with completion expected by October 2028.
CONDITIONS
Brief Title
Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18
- Suspected soft tissue sarcoma with an indication for surgical treatment
- Suspected bone cancer tumor with an indication for surgical treatment
- Ability to give informed consent
You will not qualify if you...
- Simultaneous cancer or history of cancer within the last 5 years
- Acute or chronic serious conditions that could interfere with the study
- Contraindications to contrast-enhanced MRI including:
- Renal failure without dialysis
- Allergy to paramagnetic contrast agents
- Claustrophobia
- Symptomatic epilepsy or history of epilepsy
- Cardiac pacemaker
- Infusion pump, prosthesis, or implants incompatible with MRI
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants undergo 3T multiparametric MRI to assess musculoskeletal tumors before surgery.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed for up to 2 years to evaluate tumor infiltration outcomes.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
V
Vincenzo Lucidi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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