Completed

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)

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Bone Diseases+2

+ Bone Neoplasms

+ Musculoskeletal Diseases

+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2021
See protocol details

Summary

Principal SponsorCentral Hospital, Nancy, France
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleMulticentric 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
Principal SponsorCentral Hospital, Nancy, France
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone NeoplasmsMusculoskeletal DiseasesNeoplasmsNeoplasms by Site

Criteria

3 inclusion criteria required to participate
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 exclusion criteria prevent from participating
Prio surgery

History of neoadjuvant threatment

Contra-indications to contrast enhanced MRI

Diffuse bone pathology

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Suspended

University hospital of Nancy

Nancy, FranceOpen University hospital of Nancy in Google Maps
Suspended

Hôpital Universitaire Paris Centre site Cochin APHP

Paris, France
Suspended

Centre Oscar Lambret

Lille, France
Suspended

Groupement des Hopitaux de l'institut catholique de Lille

Lille, France
Completed9 Study Centers