TUMOSTEO: Osteoarticular Tumor Characterization by Advanced Imaging

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02895633

Collaborator

(none)

1,090

Enrollment

Location

Arm

132

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Tumor Soft Tissue Tumor	Other: Ecography Other: CT scan Other: MRI	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1090 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Osteoarticular Tumor Characterization by Advanced Imaging

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 [baseline]
0: absent 1: low (< 20UH) 2: > 20 UH without new blood vessels 3: > 20 UH and/or with new blood vessels
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 [baseline]
Choline presence was defined as a clear metabolite peak at 3.2 ppm
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging [baseline]
ADC value in mm2/s
Area under the perfusion curve in MRI [baseline]
Perfusion curve gradient in MRI [baseline]
Perfusion time-to-peak in MRI [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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