Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT02383901 - A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX N/A
Active, not recruiting NCT01758666 - A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy N/A
Completed NCT01674101 - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy N/A
Completed NCT01615640 - Diffusion Study on Patients With Osteosarcoma
Completed NCT00523419 - Chemotherapy for Patients With Osteosarcoma Phase 2
Completed NCT00520936 - A Study of Pemetrexed in Children With Recurrent Cancer Phase 2
Completed NCT00132158 - ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Not yet recruiting NCT04319874 - Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma Phase 2
Recruiting NCT06029218 - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy N/A
Recruiting NCT05642455 - SPEARHEAD-3 Pediatric Study Phase 1/Phase 2
Recruiting NCT06117878 - Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma Early Phase 1
Not yet recruiting NCT04316091 - A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma Phase 1
Recruiting NCT03932058 - Proteomics Research of Osteosarcoma
Withdrawn NCT01236586 - RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia Phase 1
Completed NCT00743496 - A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma Phase 1
Recruiting NCT04040205 - Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Phase 2
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03628209 - Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma Phase 1/Phase 2