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

NCT ID: NCT01780779

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Ewing Sarcoma Osteosarcoma

Keywords

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Diffusion weighted MRI Patient outcome assessment Treatment response Histopathology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

MRI

Intervention Type 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

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

MRI

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Steven Pans

Medical Doctor Radiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Steven Pans, MD

Role: CONTACT

Phone: 3216340505

Email: [email protected]

Facility Contacts

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Steven Pans, MD

Role: primary

Other Identifiers

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S51516

Identifier Type: OTHER

Identifier Source: secondary_id

FUBEO

Identifier Type: -

Identifier Source: org_study_id