Bone NeoplasmBTI-RADS MNCT04884048
Multicentric Bone Tumor Imaging Report and Data System
An observational study of Bone Neoplasm, run by Central Hospital, Nancy, France at 9 sites in France.
Trial summary
In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Neoplasm
- What is being tested?
- Radiographs
- How many people
- 1,100 participants
- Where
- 9 sitesFrance
- Study dates
- 1 May 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred for the initial imaging characterization of focal bone lesions.
Who may be able to join
- Patient evaluated for the initial imaging characterization of a focal bone lesion.
- Availability of conventional radiographs or a CT study for patients with lesions in the spine, pelvis or calvarium.
- Availability of a contrast enhanced MRI study.
Who cannot join
- Prio surgery
- History of neoadjuvant threatment
- Contra-indications to contrast enhanced MRI
- Diffuse bone pathology
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHRU Besançon
Besançon, 25000
Chu Bordeaux
Bordeaux, 33000
Centre Oscar Lambret
Lille, Nord, 59000
Groupement des Hopitaux de l'institut catholique de Lille
Lille, Nord, 59020
CHRU Lille
Lille, Nord, 59037
Université Lyon 1 - Centre Hospitalier Lyon-Sud
Lyon, 69310
University hospital of Nancy
Nancy, Grand Est, 54000
Hôpital Universitaire Paris Centre site Cochin APHP
Paris, Ille de France, 75014
Hôpital de Purpan - CHU Toulouse
Toulouse, 31300
About this study
Official title: Multicentric Study for the Validation and Improvement of a Structured Report Tool for the Imaging Characterization of Bone Tumors - Bone Tumor Imaging Report and Data System (BTI-RADS)
In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors.
Read the detailed description
The characterization of focal bone lesions by imaging can be difficult. Primary bone sarcomas are rare, accounting for 0.2% of all malignant tumors occurring at an estimated rate of one tenth that of soft tissue sarcomas. Focal bone lesions have a wide differential diagnosis, including benign and malignant neoplasms, metabolic disorders, degenerative changes, and tumor-like conditions. The precise differentiation between benign and malignant bone tumors is essential for optimal patient management, with a considerable impact on prognosis and survival rates. The relapse-free survival of patients with sarcoma is significantly better when treatment is guided by a multidisciplinary oncology committee. In addition, surgical treatment in referral centers reduces the risk of recurrence and death.
Due to the rarity of primary malignant bone neoplasms and the varied imaging presentation of focal bone lesions, radiologists outside of cancer centers tend to have little experience with this type of abnormality. Thus, imaging reports can be unclear and misleading, increasing the risk of misdiagnosis and suboptimal patient management. Previous studies have largely addressed the specific imaging features of bone tumors, and a systematic approach to the assessment of bone tumors has been recommended. However, there is little information on how to combine these imaging results and which are most relevant for characterization of lesions.
Various studies have demonstrated the value of structured analysis of medical information in clinical decision making and such an approach is currently used for the assessment of malignancy in various organs and systems. For bone tumors, this approach requires the combined analysis of several demographic, clinical and imaging characteristics. Of the large number of features described, 16 (seven benign and nine malignant) were considered relevant for the differentiation between benign and malignant tumors. Three signs (Lodwick-Madewell grade III, aggressive periosteal reaction and suspected or confirmed metastatic disease) had a mean frequency of associated malignancy greater than 80%. Thus, lesions showing any of these signs should be considered malignant until proven otherwise. It should be noted that these 3 signs are CT or standard radiography criteria, confirming the essential role of X-ray-based methods for the characterization of bone tumors. On the contrary, certain signs classically suggestive of malignancy, such as a history of pain, pathological fracture and endosteal scalloping, have been identified as non-determining indicators for the characterization of these lesions. These data could contribute to a more precise assessment of the aggressive potential of a bone tumor. Finally, on the basis of these results, an evidence-based classification of solitary bone lesions (BTI-RADS) was proposed, allowing the stratification of bone tumors into four classes with an average frequency of malignancy of 0%; 2.2% (1.1 - 3.1%), 20.1% (17 - 24.4%) and 71% (65.6 - 75%) for each class. This system was applicable for readers with different levels of expertise, including a general radiologist, with acceptable interobserver reproducibility (Kappa = 0.67). BTI-RADS could be particularly beneficial outside of specialized oncology centers.
However, the BTI-RADS was established based on a single-center analysis of a relatively small patient population. The application of this system in a larger population in multicentric study is necessary to validate this tool and potentially refine it through the identification of additional pertinent criteria for lesion characterization.
- Conditions
- Bone Neoplasm
- Being tested
- Radiographs
- Keywords
- Bone Neoplasms, Multidetector Computed Tomography, Radiographs, Magnetic Resonance Imaging, Evidence-Based Medicine
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiographsDiagnostic test
Also called CT, MRI
Analysis of the images acquired for the initial characterization of bone lesions using a systematic report system
| Study group | Role | What they receive |
|---|---|---|
| Benign bone tumors | Patients with benign lesions confirmed either by histology or imaging follow-up showing lesion stability. Receives: Diagnostic Test: Radiographs | |
| Malignant bone tumors | Patients with malignant lesions confirmed by histology. Receives: Diagnostic Test: Radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured report item analysis
Each component of the structure report system will be analyzed and compared between the study groups.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 May 2021
- Primary completion1 May 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone NeoplasmStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement des Hôpitaux de l'Institut Catholique de Lille, Hôpital Cochin, Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Centre Hospitalier Universitaire de Besancon, Centre Oscar Lambret, Hospital Purpan, University Hospital, Lille, University Hospital, Bordeaux
- Responsible party
- Principal investigator, Pedro TEIXEIRA-GONDIM, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884048
- Sponsor's protocol ID
- CentralHNF BTI-RADSM
- Acronym
- BTI-RADS M
- Status last verified
- Jun 2026
- First submitted
- 7 May 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.
PubMed 33765161Lemore A, Vogt N, Oster J, Germain E, Fauvel M, Gillet R, Sirveaux F, Marie B, Sans N, Faruch M, Lapegue F, Lafourcade F, Badr S, Cotten A, Mihoubi Bouvier F, Yang S, Drape JL, Pastor M, Thouvenin Y, Baron MP, Cyteval C, Fadli D, Fournier C, Hauger O, Ben Haj Amor M, Stacoffe N, Daubie S, Noel JB, Pialat JB, Cherix S, Zanchi F, Omoumi P, Blum A, Hossu G, Gondim Teixeira PA. Enhanced CT and MRI Focal Bone Tumor Classification with Machine Learning-based Stratification: A Multicenter Retrospective Study. Radiology. 2025 Apr;315(1):e232834. doi: 10.1148/radiol.232834.
PubMed 40261174
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study for the Validation and Improvement of a Structured Report Tool for the Imaging Characterization of Bone Tumors - Bone Tumor Imaging Report and Data System (BTI-RADS)
- ClinicalTrials.gov ID
- NCT04884048
- Acronym / sponsor ID
- BTI-RADS M / CentralHNF BTI-RADSM
- Conditions
- Bone Neoplasm
- Keywords
- Bone Neoplasms, Multidetector Computed Tomography, Radiographs, Magnetic Resonance Imaging, Evidence-Based Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Groupement des Hôpitaux de l'Institut Catholique de Lille, Hôpital Cochin, Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Centre Hospitalier Universitaire de Besancon, Centre Oscar Lambret, Hospital Purpan, University Hospital, Lille, University Hospital, Bordeaux
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 12 May 2021 (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.
In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors.
Detailed description
The characterization of focal bone lesions by imaging can be difficult. Primary bone sarcomas are rare, accounting for 0.2% of all malignant tumors occurring at an estimated rate of one tenth that of soft tissue sarcomas. Focal bone lesions have a wide differential diagnosis, including benign and malignant neoplasms, metabolic disorders, degenerative changes, and tumor-like conditions. The precise differentiation between benign and malignant bone tumors is essential for optimal patient management, with a considerable impact on prognosis and survival rates. The relapse-free survival of patients with sarcoma is significantly better when treatment is guided by a multidisciplinary oncology committee. In addition, surgical treatment in referral centers reduces the risk of recurrence and death.
Due to the rarity of primary malignant bone neoplasms and the varied imaging presentation of focal bone lesions, radiologists outside of cancer centers tend to have little experience with this type of abnormality. Thus, imaging reports can be unclear and misleading, increasing the risk of misdiagnosis and suboptimal patient management. Previous studies have largely addressed the specific imaging features of bone tumors, and a systematic approach to the assessment of bone tumors has been recommended. However, there is little information on how to combine these imaging results and which are most relevant for characterization of lesions.
Various studies have demonstrated the value of structured analysis of medical information in clinical decision making and such an approach is currently used for the assessment of malignancy in various organs and systems. For bone tumors, this approach requires the combined analysis of several demographic, clinical and imaging characteristics. Of the large number of features described, 16 (seven benign and nine malignant) were considered relevant for the differentiation between benign and malignant tumors. Three signs (Lodwick-Madewell grade III, aggressive periosteal reaction and suspected or confirmed metastatic disease) had a mean frequency of associated malignancy greater than 80%. Thus, lesions showing any of these signs should be considered malignant until proven otherwise. It should be noted that these 3 signs are CT or standard radiography criteria, confirming the essential role of X-ray-based methods for the characterization of bone tumors. On the contrary, certain signs classically suggestive of malignancy, such as a history of pain, pathological fracture and endosteal scalloping, have been identified as non-determining indicators for the characterization of these lesions. These data could contribute to a more precise assessment of the aggressive potential of a bone tumor. Finally, on the basis of these results, an evidence-based classification of solitary bone lesions (BTI-RADS) was proposed, allowing the stratification of bone tumors into four classes with an average frequency of malignancy of 0%; 2.2% (1.1 - 3.1%), 20.1% (17 - 24.4%) and 71% (65.6 - 75%) for each class. This system was applicable for readers with different levels of expertise, including a general radiologist, with acceptable interobserver reproducibility (Kappa = 0.67). BTI-RADS could be particularly beneficial outside of specialized oncology centers.
However, the BTI-RADS was established based on a single-center analysis of a relatively small patient population. The application of this system in a larger population in multicentric study is necessary to validate this tool and potentially refine it through the identification of additional pertinent criteria for lesion characterization.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign bone tumors | – | Diagnostic Test: RadiographsPatients with benign lesions confirmed either by histology or imaging follow-up showing lesion stability. |
| Malignant bone tumors | – | Diagnostic Test: RadiographsPatients with malignant lesions confirmed by histology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred for the initial imaging characterization of focal bone lesions.
Key inclusion criteria (3 listed)
- Patient evaluated for the initial imaging characterization of a focal bone lesion.
- Availability of conventional radiographs or a CT study for patients with lesions in the spine, pelvis or calvarium.
- Availability of a contrast enhanced MRI study.
Key exclusion criteria (4 listed)
- Prio surgery
- History of neoadjuvant threatment
- Contra-indications to contrast enhanced MRI
- Diffuse bone pathology
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 |
|---|---|---|
| RadiographsAlso: CT, MRIAnalysis of the images acquired for the initial characterization of bone lesions using a systematic report system | Diagnostic test | Benign bone tumors, Malignant bone tumors |
Primary outcome
Structured report item analysis
Time frame: 30 minutes
Each component of the structure report system will be analyzed and compared between the study groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 33765161Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.
- Results publication: PubMed 40261174Lemore A, Vogt N, Oster J, Germain E, Fauvel M, Gillet R, Sirveaux F, Marie B, Sans N, Faruch M, Lapegue F, Lafourcade F, Badr S, Cotten A, Mihoubi Bouvier F, Yang S, Drape JL, Pastor M, Thouvenin Y, Baron MP, Cyteval C, Fadli D, Fournier C, Hauger O, Ben Haj Amor M, Stacoffe N, Daubie S, Noel JB, Pialat JB, Cherix S, Zanchi F, Omoumi P, Blum A, Hossu G, Gondim Teixeira PA. Enhanced CT and MRI Focal Bone Tumor Classification with Machine Learning-based Stratification: A Multicenter Retrospective Study. Radiology. 2025 Apr;315(1):e232834. doi: 10.1148/radiol.232834.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Neoplasm, run by Central Hospital, Nancy, France at 9 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured report item analysis (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884048, which also lists 2 linked publications.
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 17 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.