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Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02186262
Acronym
RODIG
Enrollment
36
Registered
2014-07-10
Start date
2014-03-31
Completion date
2017-12-31
Last updated
2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Grade Glioma, Malignant Glioma

Keywords

Glioma, MRI, Rotating frame relaxation, DWI, treatment response

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.

Interventions

None listed

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding areaPrior to surgical resectionDifferent 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

MeasureTime frameDescription
Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapyBefore, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapyChange 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026