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Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults (FUBEO)

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ClinicalTrials.gov Identifier: NCT01780779
Recruitment Status : Unknown
Verified January 2013 by Steven Pans, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Steven Pans, Universitaire Ziekenhuizen Leuven

Study Description
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Brief Summary:

The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery.

Second purpose : to define apparent diffusion coefficient value of the bone sarcoma.

Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.


Condition or disease Intervention/treatment
Ewing Sarcoma Osteosarcoma Other: MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults
Study Start Date : June 2009
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Osteosarcoma

All patients with Osteosarcoma), proven by surgical biopsy and histopathology.

All included patients will be treated by chemotherapy (EURAMOS protocol)

An MRI will be performed before, during and post-treatment

 Other: MRI

MRI exam will be performed in all patients included in the study. The patients will be treated by chemotherapy, defined in the EURO-EWING or EURAMOS protocol.

The MR findings will not have any impact on the treatment.
Ewing Sarcoma

All patients with proven diagnosis of Ewing sarcoma, proven by surgical biopsy and histopathology.

All included patients will be treated by chemotherapy (EURO-EWING protocol)

An MRI will be performed in all included patients before, during and after the chemotherapy

 Other: MRI

MRI exam will be performed in all patients included in the study. The patients will be treated by chemotherapy, defined in the EURO-EWING or EURAMOS protocol.

The MR findings will not have any impact on the treatment.


Outcome Measures
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Primary Outcome Measures :
  1. tumor necrosis - therapy response [ Time Frame: 6 months ]

    correlation of MRI findings with clinical findings during chemotherapy correlation of diffusion weighted MRI and histopathology results after surgical resection.

    Calculation of apparent diffusion coefficient : is it a valuable parameter?



Secondary Outcome Measures :
  1. Prognosis and outcome [ Time Frame: 2 years ]
    Is there a correlation between early treatment response and outcome? Is diffusion weighted MRI able to predict outcome of the patient (prognostic factor)?


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Ewing sarcoma or Osteosarcoma, proven by biopsy and histolopathology.
Criteria

Inclusion Criteria:

  • Ewing or Osteosarcoma, proven by biopsy and histopathology
  • all patients are treated by chemotherapy defined by EURAMOS and EURO-EWING protocol

Exclusion Criteria:

  • Patients under the age of 6 years old
  • patients with contra-indication for MR exam (pace-maker...)
  • Patients with renal insufficiency
  • Claustrophobia
Contacts and Locations
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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): NCT01780779


Contacts
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Contact: Steven Pans, MD 3216340505 steven.pans@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Steven Pans, MD    3216340505    steven.pans@uzleuven.be   
Principal Investigator: Pans Steven, MD         
Principal Investigator: Steven Pans, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Steven Pans, Medical Doctor Radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01780779    
Other Study ID Numbers: FUBEO
S51516 ( Other Identifier: Ethical Committee Univ.Hospital )
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by Steven Pans, Universitaire Ziekenhuizen Leuven:
Diffusion weighted MRI
Patient outcome assessment
Treatment response
Histopathology
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue