Soft Tissue Sarcoma (STS)NCT06774729
Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor
An observational study of Soft Tissue Sarcoma (STS) and Bone Cancer Tumor, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma (STS), Bone Cancer Tumor
- How many people
- 122 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2025to Oct 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- symptomatic epilepsy or history of epilepsy
- cardiac pacemaker
- infusion pump, prosthesis or any implant not compatible with MRI
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Vincenzo Lucidi, MD, +39 3385246923, vincenzo.lucidi@aosp.bo.it
About this study
Official 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
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:
Read more
- 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
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774729
- Sponsor's protocol ID
- MIT3
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06774729
- Acronym / sponsor ID
- MIT3
- Conditions
- Soft Tissue Sarcoma (STS), Bone Cancer Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma (STS) and Bone Cancer Tumor, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Lucidi, MD (+39 3385246923, vincenzo.lucidi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) (time frame: From enrollment to the end of treatment at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.