Osteoarticular Tumor Characterization by Advanced Imaging (TUMOSTEO)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Bone Tumor; Soft Tissue Tumor

Treatments: Other: Ecography; Other: CT scan; Other: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02895633

2009-A00758-49

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,090 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,090 participants in 1 patient group

Patients with bone or peripheral soft-tissue tumor

Experimental group

Treatment:

Other: Ecography

Other: CT scan

Other: MRI