Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas (RODIG)

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.

Study Overview

• Status: Completed
• Conditions: Malignant Glioma; Low Grade Glioma

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, FI-20520
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a brain tumor scheduled for a surgical resection at the Turku University Hospital, Finland.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Primary gliomas, Recurrent gliomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Heikki R Minn, Professor, Turku University Hospital, Department of Oncology and Radiotherapy

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: MRI; Glioma; DWI; treatment response; Rotating frame relaxation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 1234 (Department of Defense)