Differentiation between relapse and therapy-associated transformations in high-grade glioma by PET/MRT
Not Applicable
- Conditions
- Glioma WHO-Grading II-IVC71Malignant neoplasm of brain
- Registration Number
- DRKS00013453
- Lead Sponsor
- Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Neuroradiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 119
Inclusion Criteria
age: 18-80 years,
histopathol.-confirmed Glioma WHO II-IV,
after adj. radiochemotherapy and suspicion of a relapse (regular MRT-guided follow-up),
informed consent
Exclusion Criteria
precnancy/breast feeding women,
limited contractual capability,
inability to lie quiescent for ca. 100 min (due to pain, claustrophobia, etc.),
general contra-indication for MRT such as metallic implants, pacemaker etc.,
contra-indication for MR-contrast agent Gadolinium (known allergy, <60 GFR ml/min/1,73m2)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Imaging of therapy-induced effects in the parenchyma of the brain. This will be done by comparism of multiparametric data sets based on diffusion-, perfusion-, Arterial Spin Labeling (ASL)-, spectroscopy-, PET-, and conventional MRT-examination.
- Secondary Outcome Measures
Name Time Method Determination of sensitivity/specificity of PET/MRI detecting lesions,<br>evaluation of negative/positive predictive value of different PET/MR parameters for the early detection of therapy-induced effects (pseudo-progression or pseudo-regression),<br>The final characterization of lesions will be done either by analysis of biopsies (re-OP, 1. reference (histopathological) standard) or three sequential MRTs in nine month follow-up (2. reference (clinical) standard showing either progression or regression) and correlated to PET/MR diagnostic.<br>