Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

NCT02186262 | Completed

• 1 other identifier: 1234
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Grade Glioma; Malignant Glioma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Primary gliomas, Recurrent gliomas

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, FI-20520, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, frozen tumor tissue

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Heikki R Minn, Professor

  Turku University Hospital, Department of Oncology and Radiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 10, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

FI (1)