NCT04884048

Brief Summary

In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

9 active sites

Status
completed

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 Start

First participant enrolled

May 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

May 7, 2021

Last Update Submit

June 5, 2023

Conditions

Bone Neoplasm

Keywords

Bone NeoplasmsMultidetector Computed TomographyRadiographsMagnetic Resonance ImagingEvidence-Based Medicine

Outcome Measures

Primary Outcomes (1)

  • Structured report item analysis

    Each component of the structure report system will be analyzed and compared between the study groups.

    30 minutes

Study Arms (2)

Benign bone tumors

Patients with benign lesions confirmed either by histology or imaging follow-up showing lesion stability.

Diagnostic Test: Radiographs

Malignant bone tumors

Patients with malignant lesions confirmed by histology.

Diagnostic Test: Radiographs

Interventions

RadiographsDIAGNOSTIC_TEST

Analysis of the images acquired for the initial characterization of bone lesions using a systematic report system

Also known as: CT, MRI
Benign bone tumorsMalignant bone tumors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for the initial imaging characterization of focal bone lesions.

You may qualify if:

  • Patient evaluated for the initial imaging characterization of a focal bone lesion.
  • Availability of conventional radiographs or a CT study for patients with lesions in the spine, pelvis or calvarium.
  • Availability of a contrast enhanced MRI study.

You may not qualify if:

  • Prio surgery
  • History of neoadjuvant threatment
  • Contra-indications to contrast enhanced MRI
  • Diffuse bone pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University hospital of Nancy

Nancy, Grand Est, 54000, France

Location

Hôpital Universitaire Paris Centre site Cochin APHP

Paris, Ille de France, 75014, France

Location

Centre Oscar Lambret

Lille, Nord, 59000, France

Location

Groupement des Hopitaux de l'institut catholique de Lille

Lille, Nord, 59020, France

Location

CHRU Lille

Lille, Nord, 59037, France

Location

CHRU Besançon

Besançon, 25000, France

Location

Chu Bordeaux

Bordeaux, 33000, France

Location

Université Lyon 1 - Centre Hospitalier Lyon-Sud

Lyon, 69310, France

Location

Hôpital de Purpan - CHU Toulouse

Toulouse, 31300, France

Location

Related Publications (1)

  • Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.

    PMID: 33765161BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 12, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Locations

FR(9)