MR Perfusion Methods in Patients With Suspected Recurrent High Grade Gliomas
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|ClinicalTrials.gov Identifier: NCT02919865|
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Device: MR perfusion imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of MR Perfusion Without and With Gadolinium at 3T in the Diagnosis of Patients With Suspected Recurrent High Grade Gliomas|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
MRI perfusion imaging
Patients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study.
Device: MR perfusion imaging
MR perfusion imaging will be performed in addition to the routine neuronavigational sequence obtained from re-operative/therapy planning.
Following MR examination, patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon.
All patients, including those who do not go to surgery, will undergo clinical follow-up and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who do not undergo surgery.
- Estimate the Receiver Operating Characteristic (ROC) curve [ Time Frame: up to 22 months ]Estimate the Receiver Operating Characteristic (ROC) curve for the assessment of the diagnostic accuracy of f, CBF, CBV, Cp and Ktrans, obtained from different MR perfusion acquisition methods for distinguishing recurrent tumour from radiation necrosis.
- Different T1 mapping methods used for DCE-MRI will be compared to the current gold standard [ Time Frame: up to 22 months ]Different T1 mapping methods used for DCE-MRI (MOLLI that measures apparent T1 and SMARTMap that measures true T1) will be compared to the current gold standard (inversion recovery).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919865
|Contact: Thanh Nguyen, MD||613-798-5555 ext email@example.com|