Clinical trial NCT02895633: Osteoarticular Tumor Characterization by Advanced Imaging
Official title: Osteoarticular Tumor Characterization by Advanced Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Tumor
Soft Tissue Tumor
Keywords: MR imaging
Diffusion weighted imaging
MR proton spectroscopy
CT perfusion
Contrast enhanced ultrasound
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Contrast enhancement in echography: yes or no
timeFrame: baseline
measure: Contrast enhancement curve (absent, slow or fast) in echography
timeFrame: baseline
measure: Maximal intensity of enhancement peak in echography
timeFrame: baseline
measure: Mean transit time of enhancement in echography
timeFrame: baseline
measure: Gradient of contrast enhancement curve in echography
timeFrame: baseline
measure: Vascularization (dynamic analysis) in CT scanner
timeFrame: baseline
measure: Contrast enhancement curve (absent, slow or fast) in CT scanner
timeFrame: baseline
measure: Maximal intensity of enhancement peak in CT scanner
timeFrame: baseline
measure: Mean transit time of enhancement in CT scanner
timeFrame: baseline
measure: Gradient of contrast enhancement curve in CT scanner
timeFrame: baseline
measure: Contrast enhancement curve (absent, slow or fast) in MRI
timeFrame: baseline
measure: Maximal intensity of enhancement peak in MRI
timeFrame: baseline
measure: Mean transit time of enhancement in MRI
timeFrame: baseline
measure: Gradient of contrast enhancement curve in MRI
timeFrame: baseline
measure: Choline peak in magnetic resonance spectroscopy
timeFrame: baseline
measure: Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging
timeFrame: baseline
measure: Area under the perfusion curve in MRI
timeFrame: baseline
measure: Perfusion curve gradient in MRI
timeFrame: baseline
measure: Perfusion time-to-peak in MRI
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service d'Imagerie Guilloz, CHRU Nancy
Study officials:
affiliation: Service d'Imagerie Guilloz, CHRU Nancy
name: Pedro Augusto GONDIM TEIXEIRA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.