NCT04394052

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2020Jun 2030

First Submitted

Initial submission to the registry

May 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

July 21, 2020

Status Verified

May 1, 2020

Enrollment Period

6 years

First QC Date

May 12, 2020

Last Update Submit

July 20, 2020

Conditions

Soft Tissue NeoplasmBone Neoplasm

Keywords

MRICTTexture analysisUltra-high resolutionTumorsMusculoskeletal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sarcoma FNCLCC (fédération Nationale des Centres de Lutte Contre le Cancer) grade

    Performed up to 1 year after CT and MR imaging

Study Arms (2)

Soft-tissue tumors

Benign and malignant soft tissue masses

Diagnostic Test: MR imaging

Bone tumors

Benign and malignant bone focal bone lesions

Diagnostic Test: MR imaging

Interventions

MR imagingDIAGNOSTIC_TEST

Medical imaging

Also known as: Ultra-high resolution CT
Bone tumorsSoft-tissue tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Breast feeding patients
  • Renal insufficiency
  • Contra indications to MRI or CT
  • Prior surgery or treatment to the evaluated lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU-Nancy

Nancy, Lorraine, 54000, France

RECRUITING

MeSH Terms

Conditions

Soft Tissue NeoplasmsBone NeoplasmsNeoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Pedro Gondim Teixieira, PhD

CONTACT

+33 3 83 85 21 61p.teixeira@chru-nancy.fr

Gabriela Hossu, PhD

CONTACT

+33 3 83 15 50 96g.hossu@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 19, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2030

Last Updated

July 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)