Ewing SarcomaFUBEONCT01780779
Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults
An observational study of Ewing Sarcoma and Osteosarcoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Ewing Sarcoma, Osteosarcoma
- What is being tested?
- MRI
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with Ewing sarcoma or Osteosarcoma, proven by biopsy and histolopathology.
Who may be able to join
- Ewing or Osteosarcoma, proven by biopsy and histopathology
- all patients are treated by chemotherapy defined by EURAMOS and EURO-EWING protocol
Who cannot join
- Patients under the age of 6 years old
- patients with contra-indication for MR exam (pace-maker...)
- Patients with renal insufficiency
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Steven Pans, MD, 3216340505, steven.pans@uzleuven.be
Pans Steven, MD
About this study
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
- Being tested
- MRI
- Keywords
- Diffusion weighted MRI, Patient outcome assessment, Treatment response, Histopathology
- Medical subject headings
- Sarcoma, Ewing, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 months
Secondary outcomes (1)
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)?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJun 2009
- Primary completionJun 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Pans, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780779
- Sponsor's protocol ID
- FUBEO
- Other IDs
- S51516
- Acronym
- FUBEO
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults
- ClinicalTrials.gov ID
- NCT01780779
- Acronym / sponsor ID
- FUBEO / FUBEO
- Conditions
- Ewing Sarcoma, Osteosarcoma
- Keywords
- Diffusion weighted MRI, Patient outcome assessment, Treatment response, Histopathology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteosarcoma | – | Other: MRIAll 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 | – | Other: MRIAll 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 |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with Ewing sarcoma or Osteosarcoma, proven by biopsy and histolopathology.
Key inclusion criteria (2 listed)
- Ewing or Osteosarcoma, proven by biopsy and histopathology
- all patients are treated by chemotherapy defined by EURAMOS and EURO-EWING protocol
Key exclusion criteria (4 listed)
- Patients under the age of 6 years old
- patients with contra-indication for MR exam (pace-maker...)
- Patients with renal insufficiency
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI 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. | Other | Ewing Sarcoma, Osteosarcoma |
Primary outcome
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?
1 secondary outcome
Prognosis and outcome
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ewing Sarcoma and Osteosarcoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Pans, MD (3216340505, steven.pans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor necrosis - therapy response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.