Clinical trial · Observational
Multicentric Bone Tumor Imaging Report and Data System
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)
NCT04884048CI-TRIAL-00115017BTI-RADS McompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasm | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiographs | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Benign bone tumors
- description
- Patients with benign lesions confirmed either by histology or imaging follow-up showing lesion stability.
- interventionNames
- Diagnostic Test: Radiographs
- label
- Malignant bone tumors
- description
- Patients with malignant lesions confirmed by histology.
- interventionNames
- Diagnostic Test: Radiographs
Primary outcomes (1)
- measure
- Structured report item analysis
- timeFrame
- 30 minutes
- description
- Each component of the structure report system will be analyzed and compared between the study groups.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Prio surgery * History of neoadjuvant threatment * Contra-indications to contrast enhanced MRI * Diffuse bone pathology
References
Publications (2)
- BACKGROUNDRibeiro 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. PMID 33765161
- RESULTLemore 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. PMID 40261174