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

• Conditions: Ewing Sarcoma; Osteosarcoma
• Interventions: Other: MRI

• Registration Number: NCT01780779
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-28
• Last Update Submitted: 2013-01-28
• Study First Posted: 2013-01-31
• Last Update Posted: 2013-01-31
• Primary Completion: 2013-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteosarcoma	MRI	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
Ewing Sarcoma	MRI	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

Primary Outcome Measures

Name	Time	Method
tumor necrosis - therapy response	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

Name	Time	Method
Prognosis and outcome	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)?

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium