Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II

Bone Neoplasm Clinical Trial

— TUMOSTEO II  

Official title:

Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394052
• Other study ID #: 2019PI253
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 1, 2030

Study information

• Verified date: May 2020
• Source: Central Hospital, Nancy, France
• Contact: Pedro Gondim Teixieira, PhD
• Phone: +33 3 83 85 21 61
• Email: p.teixeira[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.

Description:

Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.

Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.

Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.

Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.

Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 740
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suspected to have a bone or soft-tissue tumor referred for imaging for initial tumors characterization and staging.

Exclusion Criteria:

• Pregnancy

• Breast feeding patients

• Renal insufficiency

• Contra indications to MRI or CT

• Prior surgery or treatment to the evaluated lesion.

Related Conditions & MeSH terms

• Bone Neoplasm
• Bone Neoplasms
• Neoplasms
• Soft Tissue Neoplasm
• Soft Tissue Neoplasms

Intervention

Diagnostic Test:
• MR imaging
Medical imaging

Locations

Country	Name	City	State
France	CHU-Nancy	Nancy	Lorraine

Sponsors (5)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Diagnostic and Interventional Adaptative Imaging Laboratory - IADI, Emille Gallé Surgical Center - CCEG, Lorraine Cancer Institute - ICL, Nancy's Regional University Hospital Center (CHRU-Nancy) anatomopathology department

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion benignancy or malignancy	Histologic determination of lesion aggressiveness (benign versus malignant) on core biopsy material	Performed up to 6 months after CT and Magnetic Resonance (MR) imaging
Secondary	Sarcoma FNCLCC (fédération Nationale des Centres de Lutte Contre le Cancer) grade	Histologic grade of the sarcomas included in the study population with surgical resection material	Performed up to 1 year after CT and MR imaging