Multimodal MR Imaging in Patients With Glioblastoma Treated With Dendritic Cell Therapy
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 7, 2011 | ||||
| Last Updated Date | August 1, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01657734 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Multimodal MR Imaging in Patients With Glioblastoma Treated With Dendritic Cell Therapy | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal treatment. Hence, there is a clear need for new, effective therapies, among which immune therapy has emerged as a promising treatment option. When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often confronted with images that are difficult to interpret with the conventional anatomical imaging techniques. The difference between tumour relapse and therapy-mediated changes is not always distinctive. In this project, the investigators attempt to characterize the inflammatory response with parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and MR-diffusion imaging. These techniques allow characterization of cellular properties like metabolism and tissue structure respectively. Doing so, the investigators will monitor disease evolution in order to timely detect treatment failure, thereby allowing appropriate switch in patient management. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated with glioblastoma treated with dendritic cell therapy |
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| Condition ICMJE | Malignant Gliomas | ||||
| Intervention ICMJE | Other: MR imaging
MR imaging |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: **** patients enrolled in the HGG 2003 HGG-IMMUNO 2003 trial Patients, older than 3 and younger than 60 years with relapse of high-grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma multiforme WHO grade IV), histologically diagnosed in the first stage of the disease as well as after relapse or relapse of glioma which was grade II in the First phase but grade III or IV upon relapse are treated with dendritic cell therapy (immunotherapy) as single treatment approach (No radiotherapy and/or chemotherapy). **** patients enrolled in the HGG 2010 HGG-IMMUNO 2010 trial
Exclusion Criteria: minor age |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01657734 | ||||
| Other Study ID Numbers ICMJE | S53303 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Universitaire Ziekenhuizen Leuven | ||||
| Study Sponsor ICMJE | Universitaire Ziekenhuizen Leuven | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Universitaire Ziekenhuizen Leuven | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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