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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Steven Pans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01780779
First received: January 23, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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 Intervention
Ewing Sarcoma
Osteosarcoma
Other: MRI

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • tumor necrosis - therapy response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • Prognosis and outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Is there a correlation between early treatment response and outcome? Is diffusion weighted MRI able to predict outcome of the patient (prognostic factor)?


Estimated Enrollment: 25
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   6 Years to 30 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780779

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

Locations
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

No publications provided

Responsible Party: Steven Pans, Medical Doctor Radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01780779     History of Changes
Other Study ID Numbers: FUBEO, S51516
Study First Received: January 23, 2013
Last Updated: January 28, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
Diffusion weighted MRI
Patient outcome assessment
Treatment response
Histopathology

Additional relevant MeSH terms:
Osteosarcoma
Sarcoma, Ewing's
Sarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014