RODIG: Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Sponsor

Turku University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02186262

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Grade Glioma Malignant Glioma

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Primary gliomas, Recurrent gliomas

Outcome Measures

Primary Outcome Measures

Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area [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.

Secondary Outcome Measures

Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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