CEST- Glucose Enhanced MRI for Metastatic Brain Tumours
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|ClinicalTrials.gov Identifier: NCT02796729|
Recruitment Status : Terminated (Not enough enrollment)
First Posted : June 13, 2016
Last Update Posted : January 28, 2019
This project will compare two MRI contrast agents in metastatic brain tumours in humans. More specifically, the investigators will compare the tumour contrast obtained using glucose versus the current standard gadolinium-based contrast agent (GBCA, gadobutrol, trade name Gadovist, will be used).
First, participants will receive a glucose bolus injection followed by glucose enhanced MRI. Second, participants will receive a Gd-DTPA bolus injection followed by Gd-DTPA enhanced MRI. Both contrast studies will be performed during the same MRI study, which will be under one hour long.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms, Malignant Metastasis||Procedure: Magnetic resonance imaging Drug: Gadovist (Gadobutrol) Drug: 50% dextrose solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Metastatic Brain Tumours Using Dynamic Glucose Enhanced MRI After D-glucose Injection|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Experimental: dynamic glucose enhanced MRI after D-glucose injection
IV catheter preparation: Catheter will be placed in one arm. Fasting glucose levels measured with a glucometer using a 1-2 mL sample of blood. Only participants with normal fasting blood glucose levels (70-125 mg/dL) will proceed with the study. First IV catheter will monitor blood glucose every 10 min after bolus injection until it returns to normal. Second IV catheter is placed on the opposite arm for glucose infusion and GBCA (gadobutrol) infusion.
Glucose infusion protocol: Occurs when the participant is in the MRI. Bolus injection of hospital grade 25g of 50% dextrose solution over 1 min is to increase blood glucose concentrations to about 3-4 times the normal level. Blood glucose levels should return to normal levels within 30 to 60 min.
GBCA infusion protocol: Occurs when the participant is in the MRI; approximately 20 min after glucose infusion. Standard intravenous bolus injection of 0.1mM/kg of gadobutrol (Gadovist) at an injection rate of 5 mL/sec.
Procedure: Magnetic resonance imaging
MRI offers excellent images of the brain and is an important tool for diagnosing metastatic brain tumors. MRI scans are often used to plan treatments such as surgery and radiotherapy. When imaging participants with metastatic brain tumors, a contrast agent is often injected intravenously to highlight the relatively small tumours in the MRI. The standard metal-based MRI contrast agent is Health Canada approved and contains a material called gadolinium. MRI studies that use gadolinium-based contrast agents are called gadolinium enhanced MRI.
Drug: Gadovist (Gadobutrol)
Gadobutrol (INN) (Gd-DO3A-butrol) is a gadolinium-based MRI contrast agent (GBCA).
Drug: 50% dextrose solution
50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for intravenous injection.
- Integral tumour contrast generated by GBCA and glucose experiments will be assessed using Area Under Curve (AUC). [ Time Frame: 1h procedure ]Area Under Curve (AUC) is measured using a sequence of MR images acquired before and after contrast injection. AUC values will be compared in tumour and contralateral brain areas to calculate the integral tumour contrast generated by glucose and GBCA experiments.
- Maximum instantaneous tumour contrast generated by GBCA and glucose experiments will be assessed. [ Time Frame: 1h procedure ]This metric is calculated using a single MR image acquired before contrast injection and a single image acquired after injection. The pair of images (before and after) that generates the maximum contrast is used. This metric will be used to compare contrasts generated by glucose and GBCA experiments.
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): NCT02796729
|Canada, British Columbia|
|BC Cancer Agency- Vancouver Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Michael McKenzie||BCCA|