Osteoarticular Tumor Characterization by Advanced Imaging
- Conditions
- Bone TumorSoft Tissue Tumor
- Interventions
- Other: EcographyOther: CT scanOther: MRI
- Registration Number
- NCT02895633
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1090
- patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor
- patients with normal awareness level
- patients having signed informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with bone or peripheral soft-tissue tumor Ecography - Patients with bone or peripheral soft-tissue tumor MRI - Patients with bone or peripheral soft-tissue tumor CT scan -
- Primary Outcome Measures
Name Time Method Contrast enhancement in echography: yes or no 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 vesselsContrast enhancement curve (absent, slow or fast) in CT scanner baseline Maximal intensity of enhancement peak in CT scanner baseline Maximal intensity of enhancement peak in echography baseline Mean transit time of enhancement in echography baseline Contrast enhancement curve (absent, slow or fast) in echography 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service d'Imagerie Guilloz, CHRU Nancy
🇫🇷Nancy, France