Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II (TUMOSTEO II)

July 20, 2020 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

740

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with soft-tissue and bone tumors evaluated with MR and ultra-high resolution CT.

Description

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 Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion benignancy or malignancy
Time Frame: Performed up to 6 months after CT and Magnetic Resonance (MR) imaging
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Lorraine Cancer Institute - ICL
Emille Gallé Surgical Center - CCEG
Diagnostic and Interventional Adaptative Imaging Laboratory - IADI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

June 1, 2030

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019PI253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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