Terminé

BTI-RADS MMulticentric 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)

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est collecté

Collecte de données

Données issues de dossiers médicaux ou de données préexistantes - Rétrospective
Qui peut participer

Maladies osseuses+2

+ Tumeurs osseuses

+ Maladies musculo-squelettiques

+7 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Cas témoins

Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.
Observationnel
Date de début : mai 2021
Voir le détail du protocole

Résumé

Sponsor principalCentral Hospital, Nancy, France
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 mai 2021

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielMulticentric 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)
NCT04884048
Sponsor principalCentral Hospital, Nancy, France
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

1100 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Cas témoins

Ce type d'étude compare des personnes atteintes d'une maladie à d'autres qui ne le sont pas, afin de comprendre quels facteurs ou expositions passées pourraient avoir joué un rôle dans l'apparition de la maladie.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies osseusesTumeurs osseusesMaladies musculo-squelettiquesNéoplasmes par siteNéoplasmes

Critères

3 critères d'inclusion nécessaires pour participer
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.

4 critères d'exclusion empêchent la participation
Prio surgery

History of neoadjuvant threatment

Contra-indications to contrast enhanced MRI

Diffuse bone pathology

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Objectifs de l'étude

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 9 sites

Suspendu

University hospital of Nancy

Nancy, FranceOuvrir University hospital of Nancy dans Google Maps
Suspendu

Hôpital Universitaire Paris Centre site Cochin APHP

Paris, France
Suspendu

Centre Oscar Lambret

Lille, France
Suspendu

Groupement des Hopitaux de l'institut catholique de Lille

Lille, France
Terminé9 Centres d'Étude