Low Grade GliomaRODIGNCT02186262
Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
An observational study of Low Grade Glioma and Malignant Glioma, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Grade Glioma, Malignant Glioma
- How many people
- 36 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a brain tumor scheduled for a surgical resection at the Turku University Hospital, Finland.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary gliomas, Recurrent gliomas | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to surgical resection
Secondary outcomes (1)
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.
Measured: Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade GliomaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heikki Minn, Turku University Hospital
- Investigators
- Heikki R Minn, Professor, Principal investigator, Turku University Hospital, Department of Oncology and Radiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186262
- Sponsor's protocol ID
- 1234
- Acronym
- RODIG
- Status last verified
- Jun 2018
- First submitted
- 4 Jul 2014
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
- ClinicalTrials.gov ID
- NCT02186262
- Acronym / sponsor ID
- RODIG / 1234
- Conditions
- Low Grade Glioma, Malignant Glioma
- Keywords
- Glioma, MRI, Rotating frame relaxation, DWI, treatment response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary gliomas, Recurrent gliomas | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a brain tumor scheduled for a surgical resection at the Turku University Hospital, Finland.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area
Time frame: 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.
1 secondary outcome
Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy
Time frame: Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki R Minn, Professor principal investigator
Turku University Hospital, Department of Oncology and Radiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Grade Glioma and Malignant Glioma, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area (time frame: Prior to surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.