TUMOSTEO II: Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04394052
• Collaborator: Lorraine Cancer Institute - ICL (Other), Emille Gallé Surgical Center - CCEG (Other), Diagnostic and Interventional Adaptative Imaging Laboratory - IADI (Other)
• Enrollment: 740
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Neoplasm; Bone Neoplasm	Diagnostic Test: MR imaging

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 Design

• Study Type: Observational
• Anticipated Enrollment: 740 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2026
• Anticipated Study Completion Date: Jun 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Soft-tissue tumors Benign and malignant soft tissue masses	Diagnostic Test: MR imaging; Medical imaging; Other Names: Ultra-high resolution CT
Bone tumors Benign and malignant bone focal bone lesions	Diagnostic Test: MR imaging; Medical imaging; Other Names: Ultra-high resolution CT

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU-Nancy	Nancy	Lorraine	France	54000

Sponsors and Collaborators

• Central Hospital, Nancy, France
• Lorraine Cancer Institute - ICL
• Emille Gallé Surgical Center - CCEG
• Diagnostic and Interventional Adaptative Imaging Laboratory - IADI

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT04394052
• Other Study ID Numbers: 2019PI253
• First Posted: May 19, 2020
• Last Update Posted: Jul 21, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Central Hospital, Nancy, France: MRI; CT; Texture analysis; Ultra-high resolution; Tumors; Musculoskeletal
• Additional relevant MeSH terms: Neoplasms; Bone Neoplasms; Soft Tissue Neoplasms

Study Results

No Results Posted as of Jul 21, 2020