Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas (RODIG)
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|ClinicalTrials.gov Identifier: NCT02186262|
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : June 14, 2018
Grading of gliomas is of significant clinical importance since the prognosis as well as the treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI modalities, however, a reliable distinction is often impossible. Moreover, the gold standard for glioma grading by histopathology may also have limitations due to unrepresentative tumor samples. Therefore, more advanced MRI techniques are urgently needed that would have higher sensitivity and specificity in the definition of tumor type, grade and extent.
Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria 12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify nonresponding patients earlier, preferentially midtreatment in order to consider alternative treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have provided promising results in assessing early treatment response. Furthermore, a serum biomarker with diagnostic value could improve tumor follow-up and clinical management of gliomas.
The aim of our study is to develop novel imaging protocols suitable for the magnetic resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame imaging, novel DWI acquisition and post-processing methods We also study the correlation between advanced MRI parameters and histopathology of the tumor specimen. In addition, early treatment response is assessed with advanced MRI parameters at 3 week and 10 week after initiation of radiotherapy. Finally, our objective is to study the association between serum biomarkers and corresponding MRI with potential tumor progression.
|Condition or disease|
|Low Grade Glioma Malignant Glioma|
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
|Primary gliomas, Recurrent gliomas|
- Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area [ Time Frame: Prior to surgical resection ]Different MR relaxation parameters (T1rho-adiabatic,T1rho-cw T2rho-adiabatic,... ) and diffusion values (ADCm, ADCk, K, f, Df, Ds,...) will be measured in the tumor and surrounding area. The quantitative values will be correlated with cancer aggressiveness and tissue bio-markers. Furthermore, tumor volume will be estimated using different quantitative values.
- Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy [ Time Frame: Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy ]Change in the different MR relaxation parameters (T1rho-adaibatic,T1rho-cw T2rho-adiabatic,... ) and diffusion values (ADCm, ADCk, K, f, Df, Ds,...) during tumor therapy will be estimated from repeated MR examinations performed before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186262
|Turku University Hospital|
|Turku, Finland, FI-20520|
|Principal Investigator:||Heikki R Minn, Professor||Turku University Hospital, Department of Oncology and Radiotherapy|