Malignant Glioma Clinical Trial
— RODIGOfficial title:
Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
NCT number | NCT02186262 |
Other study ID # | 1234 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | December 2017 |
Verified date | June 2018 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age: 18 to 80 years old - Language spoken: Finnish or Swedish - Performance status: Karnofsky score 70 or better or WHO performance status 2 or better - Supratentorial primary malignant glioma (the diagnosis is based on radiological and clinical grounds) - Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging - Patient is scheduled to either surgery or stereotactic biopsy - Mental status: Patients must be able to understand the meaning of the study - Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: - Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease - Any psychiatric condition that compromises the subject's ability to participate in the study - Infections: Patient must not have an uncontrolled serious infection - No contraindications for MRI (cardiac pacemaker, intracranial clips etc) - Patient must not have claustrophobia with serious symptoms - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area | 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. | Prior to surgical resection | |
Secondary | Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy | 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. | Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy |
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