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CompletedNCT04884048BTI-RADS MUpdated Jun 17, 2026

Multicentric Bone Tumor Imaging Report and Data System

An observational study in Bone Neoplasm, sponsored by Central Hospital, Nancy, France. Completed at 9 sites in France. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,100
Sex
All
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Study 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 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.

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Conditions studied

  • Bone Neoplasm

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Keywords

  • Bone Neoplasms
  • Multidetector Computed Tomography
  • Radiographs
  • Magnetic Resonance Imaging
  • Evidence-Based Medicine
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In context

Bone Neoplasms

321 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's enrollment of 1,100 is above the median of 75 across 93 observational studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for the initial imaging characterization of focal bone lesions.

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

Exclusion Criteria:

  • Prio surgery
  • History of neoadjuvant threatment
  • Contra-indications to contrast enhanced MRI
  • Diffuse bone pathology
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,100 participants (actual)
Patient registry
No

Groups and cohorts

  • Benign bone tumors

    Patients with benign lesions confirmed either by histology or imaging follow-up showing lesion stability.

    Diagnostic Test: Radiographs

  • Malignant bone tumors

    Patients with malignant lesions confirmed by histology.

    Diagnostic Test: Radiographs

Interventions

  • Diagnostic testRadiographs

    Analysis of the images acquired for the initial characterization of bone lesions using a systematic report system

    Also known as: CT, MRI

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What researchers measure

Primary outcomes

  1. Structured report item analysis

    Each component of the structure report system will be analyzed and compared between the study groups.

    Time frame: 30 minutes

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Study locations

9 sites
  • University hospital of Nancy
    Nancy, Grand Est 54000, France
  • Hôpital Universitaire Paris Centre site Cochin APHP
    Paris, Ille de France 75014, France
  • Centre Oscar Lambret
    Lille, Nord 59000, France
  • Groupement des Hopitaux de l'institut catholique de Lille
    Lille, Nord 59020, France
  • CHRU Lille
    Lille, Nord 59037, France
  • CHRU Besançon
    Besançon, 25000, France
  • Chu Bordeaux
    Bordeaux, 33000, France
  • Université Lyon 1 - Centre Hospitalier Lyon-Sud
    Lyon, 69310, France
  • Hôpital de Purpan - CHU Toulouse
    Toulouse, 31300, France
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References and documents

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 33765161 ↗
  • Lemore 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04884048
Lead sponsor
Central Hospital, Nancy, France
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
Pedro TEIXEIRA-GONDIM, MD (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
May 12, 2021
Start date
May 1, 2021
Primary completion
May 1, 2022
Completion
May 1, 2023
Last update
Jun 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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