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

Osteosarcoma Clinical Trial

— FUBEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01780779
• Other study ID #: FUBEO
• Secondary ID: S51516
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2013
• Last updated: January 28, 2013
• Start date: June 2009
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Steven Pans, MD
• Phone: 3216340505
• Email: steven.pans[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 30 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ewing Sarcoma
• Osteosarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor necrosis - therapy response	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	No
Secondary	Prognosis and outcome	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	No