Soft Tissue NeoplasmTUMOSTEO IINCT04394052
Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II
An observational study of Soft Tissue Neoplasm and Bone Neoplasm, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Neoplasm, Bone Neoplasm
- What is being tested?
- MR imaging
- How many people
- 740 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 Jun 2030
- 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: Patients with soft-tissue and bone tumors evaluated with MR and ultra-high resolution CT.
Who may be able to join
- Patients suspected to have a bone or soft-tissue tumor referred for imaging for initial tumors characterization and staging.
Who cannot join
- Pregnancy
- Breast feeding patients
- Renal insufficiency
- Contra indications to MRI or CT
- Prior surgery or treatment to the evaluated lesion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU-Nancy
Nancy, Lorraine, 54000
Pedro Gondim Teixeira, Prof, +33383852161, p.teixeira@chru-nancy.fr
Alain Blum, Prof, +33383852161, alain.blum@gmail.com
About this study
Official title: Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence
This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.
Read the detailed description
Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.
Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.
Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.
Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.
Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces.
- Conditions
- Soft Tissue Neoplasm, Bone Neoplasm
- Being tested
- MR imaging
- Keywords
- MRI, CT, Texture analysis, Ultra-high resolution, Tumors, Musculoskeletal
- Medical subject headings
- Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR imagingDiagnostic test
Also called Ultra-high resolution CT
Medical imaging
| Study group | Role | What they receive |
|---|---|---|
| Soft-tissue tumors | Benign and malignant soft tissue masses Receives: Diagnostic Test: MR imaging | |
| Bone tumors | Benign and malignant bone focal bone lesions Receives: Diagnostic Test: MR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion benignancy or malignancy
Histologic determination of lesion aggressiveness (benign versus malignant) on core biopsy material
Measured: Performed up to 6 months after CT and Magnetic Resonance (MR) imaging
Secondary outcomes (1)
Sarcoma FNCLCC (fédération Nationale des Centres de Lutte Contre le Cancer) grade
Histologic grade of the sarcomas included in the study population with surgical resection material
Measured: Performed up to 1 year after CT and MR imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue NeoplasmStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Lorraine Cancer Institute - ICL, Emille Gallé Surgical Center - CCEG, Diagnostic and Interventional Adaptative Imaging Laboratory - IADI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394052
- Sponsor's protocol ID
- 2019PI253
- Acronym
- TUMOSTEO II
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04394052
- Acronym / sponsor ID
- TUMOSTEO II / 2019PI253
- Conditions
- Soft Tissue Neoplasm, Bone Neoplasm
- Keywords
- MRI, CT, Texture analysis, Ultra-high resolution, Tumors, Musculoskeletal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Lorraine Cancer Institute - ICL, Emille Gallé Surgical Center - CCEG, Diagnostic and Interventional Adaptative Imaging Laboratory - IADI
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 19 May 2020 (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.
This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.
Detailed description
Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.
Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.
Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.
Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.
Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft-tissue tumors | – | Diagnostic Test: MR imagingBenign and malignant soft tissue masses |
| Bone tumors | – | Diagnostic Test: MR imagingBenign and malignant bone focal bone lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with soft-tissue and bone tumors evaluated with MR and ultra-high resolution CT.
Key inclusion criteria (1 listed)
- Patients suspected to have a bone or soft-tissue tumor referred for imaging for initial tumors characterization and staging.
Key exclusion criteria (5 listed)
- Pregnancy
- Breast feeding patients
- Renal insufficiency
- Contra indications to MRI or CT
- Prior surgery or treatment to the evaluated lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR imagingAlso: Ultra-high resolution CTMedical imaging | Diagnostic test | Bone tumors, Soft-tissue tumors |
Primary outcome
Lesion benignancy or malignancy
Time frame: Performed up to 6 months after CT and Magnetic Resonance (MR) imaging
Histologic determination of lesion aggressiveness (benign versus malignant) on core biopsy material
1 secondary outcome
Sarcoma FNCLCC (fédération Nationale des Centres de Lutte Contre le Cancer) grade
Time frame: Performed up to 1 year after CT and MR imaging
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 21 Jul 2020.
- Individual participant dataSharing planned: No
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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 Neoplasm and Bone Neoplasm, run by Central Hospital, Nancy, France at 1 site in France.
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 1 inclusion and 5 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 21 Jul 2020. 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 France. 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 Pedro Gondim Teixieira, PhD (+33 3 83 85 21 61, p.teixeira@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion benignancy or malignancy (time frame: Performed up to 6 months after CT and Magnetic Resonance (MR) imaging). 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 21 Jul 2020.