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Osteoarticular Tumor Characterization by Advanced Imaging (TUMOSTEO)

Primary Purpose

Bone Tumor, Soft Tissue Tumor

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ecography
CT scan
MRI
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Tumor focused on measuring MR imaging, Diffusion weighted imaging, MR proton spectroscopy, CT perfusion, Contrast enhanced ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service d'Imagerie Guilloz, CHRU NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with bone or peripheral soft-tissue tumor

Arm Description

Outcomes

Primary Outcome Measures

Contrast enhancement in echography: yes or no
Contrast enhancement curve (absent, slow or fast) in echography
Maximal intensity of enhancement peak in echography
Mean transit time of enhancement in echography
Gradient of contrast enhancement curve in echography
Vascularization (dynamic analysis) in CT scanner
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
Maximal intensity of enhancement peak in CT scanner
Mean transit time of enhancement in CT scanner
Gradient of contrast enhancement curve in CT scanner
Contrast enhancement curve (absent, slow or fast) in MRI
Maximal intensity of enhancement peak in MRI
Mean transit time of enhancement in MRI
Gradient of contrast enhancement curve in MRI
Choline peak in magnetic resonance spectroscopy
Choline presence was defined as a clear metabolite peak at 3.2 ppm
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging
ADC value in mm2/s
Area under the perfusion curve in MRI
Perfusion curve gradient in MRI
Perfusion time-to-peak in MRI

Secondary Outcome Measures

Full Information

First Posted
September 5, 2016
Last Updated
September 5, 2016
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02895633
Brief Title
Osteoarticular Tumor Characterization by Advanced Imaging
Acronym
TUMOSTEO
Official Title
Osteoarticular Tumor Characterization by Advanced Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Tumor, Soft Tissue Tumor
Keywords
MR imaging, Diffusion weighted imaging, MR proton spectroscopy, CT perfusion, Contrast enhanced ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1090 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with bone or peripheral soft-tissue tumor
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ecography
Intervention Description
Standard Doppler ultrasound and perfusion imaging after injection of Sonovue
Intervention Type
Other
Intervention Name(s)
CT scan
Intervention Description
With injection of Iomeron 400
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
With injection of gadolinium (Multihance)
Primary Outcome Measure Information:
Title
Contrast enhancement in echography: yes or no
Time Frame
baseline
Title
Contrast enhancement curve (absent, slow or fast) in echography
Time Frame
baseline
Title
Maximal intensity of enhancement peak in echography
Time Frame
baseline
Title
Mean transit time of enhancement in echography
Time Frame
baseline
Title
Gradient of contrast enhancement curve in echography
Time Frame
baseline
Title
Vascularization (dynamic analysis) in CT scanner
Description
0: absent 1: low (< 20UH) 2: > 20 UH without new blood vessels 3: > 20 UH and/or with new blood vessels
Time Frame
baseline
Title
Contrast enhancement curve (absent, slow or fast) in CT scanner
Time Frame
baseline
Title
Maximal intensity of enhancement peak in CT scanner
Time Frame
baseline
Title
Mean transit time of enhancement in CT scanner
Time Frame
baseline
Title
Gradient of contrast enhancement curve in CT scanner
Time Frame
baseline
Title
Contrast enhancement curve (absent, slow or fast) in MRI
Time Frame
baseline
Title
Maximal intensity of enhancement peak in MRI
Time Frame
baseline
Title
Mean transit time of enhancement in MRI
Time Frame
baseline
Title
Gradient of contrast enhancement curve in MRI
Time Frame
baseline
Title
Choline peak in magnetic resonance spectroscopy
Description
Choline presence was defined as a clear metabolite peak at 3.2 ppm
Time Frame
baseline
Title
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging
Description
ADC value in mm2/s
Time Frame
baseline
Title
Area under the perfusion curve in MRI
Time Frame
baseline
Title
Perfusion curve gradient in MRI
Time Frame
baseline
Title
Perfusion time-to-peak in MRI
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Augusto GONDIM TEIXEIRA
Email
ped_gt@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Augusto GONDIM TEIXEIRA
Organizational Affiliation
Service d'Imagerie Guilloz, CHRU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Imagerie Guilloz, CHRU Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33765161
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.
Results Reference
derived

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Osteoarticular Tumor Characterization by Advanced Imaging

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