Clinical trial NCT02186262: Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
Official title: Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Grade Glioma
Malignant Glioma
Keywords: Glioma
MRI
Rotating frame relaxation
DWI
treatment response
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2014-07-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a brain tumor scheduled for a surgical resection at the Turku University Hospital, Finland.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area
timeFrame: Prior to surgical resection
Secondary outcomes:
measure: Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy
timeFrame: Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital, Department of Oncology and Radiotherapy
name: Heikki R Minn, Professor
role: PRINCIPAL_INVESTIGATOR
References: