- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884048
Multicentric Bone Tumor Imaging Report and Data System (BTI-RADS M)
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)
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Besançon, France, 25000
- CHRU Besançon
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Bordeaux, France, 33000
- CHU Bordeaux
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Lyon, France, 69310
- Université Lyon 1 - Centre Hospitalier Lyon-Sud
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Toulouse, France, 31300
- Hôpital de Purpan - CHU Toulouse
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Grand-Est
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Nancy, Grand-Est, France, 54000
- University Hospital Of Nancy
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Ille De France
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Paris, Ille De France, France, 75014
- Hôpital Universitaire Paris Centre site Cochin APHP
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Nord
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Lille, Nord, France, 59000
- Centre Oscar Lambret
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Lille, Nord, France, 59037
- CHRU Lille
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Lille, Nord, France, 59020
- Groupement des Hôpitaux de l'Institut Catholique de Lille
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Benign bone tumors
Patients with benign lesions confirmed either by histology or imaging follow-up showing lesion stability.
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Analysis of the images acquired for the initial characterization of bone lesions using a systematic report system
Other Names:
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Malignant bone tumors
Patients with malignant lesions confirmed by histology.
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Analysis of the images acquired for the initial characterization of bone lesions using a systematic report system
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Structured report item analysis
Time Frame: 30 minutes
|
Each component of the structure report system will be analyzed and compared between the study groups.
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30 minutes
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CentralHNF BTI-RADSM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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