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Osteoarticular Tumor Characterization by Advanced Imaging

Osteoarticular Tumor Characterization by Advanced Imaging

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02895633
Acronym
TUMOSTEO
Enrollment
1090
Registered
2016-09-12
Start date
2009-11-30
Completion date
2020-11-30
Last updated
2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Tumor, Soft Tissue Tumor

Keywords

MR imaging, Diffusion weighted imaging, MR proton spectroscopy, CT perfusion, Contrast enhanced ultrasound

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

Interventions

OTHEREcography

Standard Doppler ultrasound and perfusion imaging after injection of Sonovue

OTHERCT scan

With injection of Iomeron 400

OTHERMRI

With injection of gadolinium (Multihance)

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Contrast enhancement curve (absent, slow or fast) in MRIbaseline
Maximal intensity of enhancement peak in MRIbaseline
Mean transit time of enhancement in MRIbaseline
Gradient of contrast enhancement curve in MRIbaseline
Contrast enhancement in echography: yes or nobaseline
Contrast enhancement curve (absent, slow or fast) in echographybaseline
Maximal intensity of enhancement peak in echographybaseline
Mean transit time of enhancement in echographybaseline
Gradient of contrast enhancement curve in echographybaseline
Vascularization (dynamic analysis) in CT scannerbaseline* 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 scannerbaseline
Maximal intensity of enhancement peak in CT scannerbaseline
Mean transit time of enhancement in CT scannerbaseline
Gradient of contrast enhancement curve in CT scannerbaseline
Choline peak in magnetic resonance spectroscopybaselineCholine presence was defined as a clear metabolite peak at 3.2 ppm
Apparent diffusion coefficient (ADC) in MR diffusion weighted imagingbaselineADC value in mm2/s
Area under the perfusion curve in MRIbaseline
Perfusion curve gradient in MRIbaseline
Perfusion time-to-peak in MRIbaseline

Countries

France

Contacts

Primary ContactPedro Augusto GONDIM TEIXEIRA
ped_gt@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026