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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
Sponsor:
Information provided by (Responsible Party):
Michael McKenzie, British Columbia Cancer Agency

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
Drug Information available for: Dextrose

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or females
  • Between 18 and 65 years of age
  • Of all ethnic groups
  • BCCA participants with at least one contrast enhancing brain mass with a diameter ≥ 1 cm and consistent with metastatic carcinoma*
  • Able to give consent
  • Willingness to participate in the study * One additional healthy participant will be included in the study to perform a 'test-run' for the complicated MRI and infusion protocol.

Exclusion Criteria:

  • Pregnancy
  • Diabetes mellitus (self-reported or HbA1C ≥ 6.5%)
  • Ferromagnetic implant or foreign metallic bodies (pacemaker, loose metal, etc.)
  • Claustrophobia
  • History of kidney disease and/or eGFR < 60
  • Abnormal fasting blood glucose (<70mg/dL or >125 mg/dL)
  • Allergic to corn
  • History of adverse reactions to gadolinium based contrast agents
  • Poor performance status (Karnofsky PS<70%)
  • Previously received whole brain radiotherapy
  • All lesions evident on imaging were previously treated with stereotactic radiosurgery
  • The participants weigh more than 300lbs
  • The participants had surgery in the last 6 weeks
  • The participants have an intrauterine device
  • The participants have cosmetic tattoos

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
BC Cancer Agency- Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Principal Investigator: Michael McKenzie BCCA

Publications:
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Responsible Party: Michael McKenzie, Radiation Oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02796729     History of Changes
Other Study ID Numbers: H16-00646
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only participants (and their most responsible physician with permission) have the option of receiving their own personal data.

Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases