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

NCT01780779 | Unknown

• 2 other identifiers: FUBEOS51516
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ewing Sarcoma; Osteosarcoma

Keywords

Diffusion weighted MRI; Patient outcome assessment; Treatment response; Histopathology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Prognosis and outcome

  2 years

Study Arms (2)

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

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

Interventions

MRI OTHER

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; Osteosarcoma

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Sarcoma, Ewing; Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Steven Pans, MD

CONTACT

3216340505; steven.pans@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Radiologist

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 31, 2013
• Study Start: June 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

BE (1)