|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02186262 |
|
Date of registration:
|
04/07/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
RODIG |
|
Scientific title:
|
Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas |
|
Date of first enrolment:
|
March 2014 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02186262 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Heikki R Minn, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Turku University Hospital, Department of Oncology and Radiotherapy |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Malignant Glioma
|
|
Low Grade Glioma
|
|
Primary Outcome(s)
|
|
Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area
[Time Frame: Prior to surgical resection]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|