Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II

Recruiting

• Conditions: Bone Neoplasm; Soft Tissue Neoplasm
• Interventions: Diagnostic Test: MR imaging

• Registration Number: NCT04394052
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-19
• Study Start: 2020-06-01
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21
• Primary Completion: 2026-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 740

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone tumors	MR imaging	Benign and malignant bone focal bone lesions
Soft-tissue tumors	MR imaging	Benign and malignant soft tissue masses

Primary Outcome Measures

Name	Time	Method
Lesion benignancy or malignancy	Performed up to 6 months after CT and Magnetic Resonance (MR) imaging	Histologic determination of lesion aggressiveness (benign versus malignant) on core biopsy material

Secondary Outcome Measures

Name	Time	Method
Sarcoma FNCLCC (fédération Nationale des Centres de Lutte Contre le Cancer) grade	Performed up to 1 year after CT and MR imaging	Histologic grade of the sarcomas included in the study population with surgical resection material

Trial Locations

Locations (1)

CHU-Nancy; 🇫🇷 Nancy, Lorraine, France