Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 95 for:    gadobenate dimeglumine

Osteoarticular Tumor Characterization by Advanced Imaging (TUMOSTEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02895633
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Bone Tumor Soft Tissue Tumor Other: Ecography Other: CT scan Other: MRI Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1090 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Osteoarticular Tumor Characterization by Advanced Imaging
Study Start Date : November 2009
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Contrast enhancement in echography: yes or no [ Time Frame: baseline ]
  2. Contrast enhancement curve (absent, slow or fast) in echography [ Time Frame: baseline ]
  3. Maximal intensity of enhancement peak in echography [ Time Frame: baseline ]
  4. Mean transit time of enhancement in echography [ Time Frame: baseline ]
  5. Gradient of contrast enhancement curve in echography [ Time Frame: baseline ]
  6. Vascularization (dynamic analysis) in CT scanner [ Time Frame: baseline ]
    • 0: absent
    • 1: low (< 20UH)
    • 2: > 20 UH without new blood vessels
    • 3: > 20 UH and/or with new blood vessels

  7. Contrast enhancement curve (absent, slow or fast) in CT scanner [ Time Frame: baseline ]
  8. Maximal intensity of enhancement peak in CT scanner [ Time Frame: baseline ]
  9. Mean transit time of enhancement in CT scanner [ Time Frame: baseline ]
  10. Gradient of contrast enhancement curve in CT scanner [ Time Frame: baseline ]
  11. Contrast enhancement curve (absent, slow or fast) in MRI [ Time Frame: baseline ]
  12. Maximal intensity of enhancement peak in MRI [ Time Frame: baseline ]
  13. Mean transit time of enhancement in MRI [ Time Frame: baseline ]
  14. Gradient of contrast enhancement curve in MRI [ Time Frame: baseline ]
  15. Choline peak in magnetic resonance spectroscopy [ Time Frame: baseline ]
    Choline presence was defined as a clear metabolite peak at 3.2 ppm

  16. Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging [ Time Frame: baseline ]
    ADC value in mm2/s

  17. Area under the perfusion curve in MRI [ Time Frame: baseline ]
  18. Perfusion curve gradient in MRI [ Time Frame: baseline ]
  19. Perfusion time-to-peak in MRI [ Time Frame: baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895633


Contacts
Layout table for location contacts
Contact: Pedro Augusto GONDIM TEIXEIRA ped_gt@hotmail.com

Locations
Layout table for location information
France
Service d'Imagerie Guilloz, CHRU Nancy Recruiting
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Principal Investigator: Pedro Augusto GONDIM TEIXEIRA Service d'Imagerie Guilloz, CHRU Nancy

Layout table for additonal information
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02895633     History of Changes
Other Study ID Numbers: 2009-A00758-49
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
MR imaging
Diffusion weighted imaging
MR proton spectroscopy
CT perfusion
Contrast enhanced ultrasound

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Soft Tissue Neoplasms
Neoplasms by Site