Osteoarticular Tumor Characterization by Advanced Imaging (TUMOSTEO)

The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.

Secondary purposes are:

• to determine a possible correlation between some parameters and the histological grade (FNCLCC)
• to suggest a coherent diagnostic imaging approach for osteoarticular tumors.

The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.

Study Overview

• Status: Unknown
• Conditions: Bone Tumor; Soft Tissue Tumor
• Intervention / Treatment: Other: Ecography; Other: CT scan; Other: MRI

Detailed Description

Patients refered for the initial evaluation of suspected osteoarticular masses will be included in this study after signing an informed consent.

Histologic analysis will be used as a gold standard.

The following imaging techniques will be evaluated:

• contrast enhanced ultrasonography
• Low dose CT perfusion
• Magnetic resonance perfusion
• Diffusion weighted imaging
• Magnetic resonance proton spectroscopy

• Study Type: Interventional
• Enrollment (Anticipated): 1090
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Augusto GONDIM TEIXEIRA; Email: ped_gt@hotmail.com

Study Locations

• France
  • Nancy, France
    • Recruiting
    • Service d'Imagerie Guilloz, CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor
• patients with normal awareness level
• patients having signed informed consent

Exclusion Criteria:

• pregnant women
• persons deprived of liberty
• persons under legal protection or unable to give informed consent
• persons in life-threatening emergency
• allergy to Sonovue, iodinated contrast media or gadolinium chelates
• risk of pregnancy
• breastfeeding women
• acute coronary syndrome or unstable ischemic cardiopathy (ban on injection of contrast agent for CT scan)
• renal failure (ban on injection of contrast agent for MRI and CT scan)
• contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with bone or peripheral soft-tissue tumor	Other: Ecography; Standard Doppler ultrasound and perfusion imaging after injection of Sonovue; Other: CT scan; With injection of Iomeron 400; Other: MRI; With injection of gadolinium (Multihance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast enhancement in echography: yes or no		baseline
Contrast enhancement curve (absent, slow or fast) in echography		baseline
Maximal intensity of enhancement peak in echography		baseline
Mean transit time of enhancement in echography		baseline
Gradient of contrast enhancement curve in echography		baseline
Vascularization (dynamic analysis) in CT scanner	0: absent; 1: low (< 20UH); 2: > 20 UH without new blood vessels; 3: > 20 UH and/or with new blood vessels	baseline
Contrast enhancement curve (absent, slow or fast) in CT scanner		baseline
Maximal intensity of enhancement peak in CT scanner		baseline
Mean transit time of enhancement in CT scanner		baseline
Gradient of contrast enhancement curve in CT scanner		baseline
Contrast enhancement curve (absent, slow or fast) in MRI		baseline
Maximal intensity of enhancement peak in MRI		baseline
Mean transit time of enhancement in MRI		baseline
Gradient of contrast enhancement curve in MRI		baseline
Choline peak in magnetic resonance spectroscopy	Choline presence was defined as a clear metabolite peak at 3.2 ppm	baseline
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging	ADC value in mm2/s	baseline
Area under the perfusion curve in MRI		baseline
Perfusion curve gradient in MRI		baseline
Perfusion time-to-peak in MRI		baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Pedro Augusto GONDIM TEIXEIRA, Service d'Imagerie Guilloz, CHRU Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 5, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 5, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Diffusion weighted imaging; CT perfusion; Contrast enhanced ultrasound; MR imaging; MR proton spectroscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Soft Tissue Neoplasms
• Other Study ID Numbers: 2009-A00758-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO