Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Malignant Glioma Clinical Trial

— RODIG  

Official title:

Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186262
• Other study ID #: 1234
• Status: Completed
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Glioma
• Low Grade Glioma
• Malignant Glioma

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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