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

January 28, 2013 updated by: Steven Pans, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:
        • Principal Investigator:
          • Pans Steven, MD
        • Principal Investigator:
          • Steven Pans, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with Ewing sarcoma or Osteosarcoma, proven by biopsy and histolopathology.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)?
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUBEO
  • S51516 (Other Identifier: Ethical Committee Univ.Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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