Metastasis Clinical Trial
Official title:
Detection of Metastatic Brain Tumours Using Dynamic Glucose Enhanced MRI After D-glucose Injection
Verified date | January 2019 |
Source | British Columbia Cancer Agency |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | BC Cancer Agency- Vancouver Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency |
Canada,
Chan KW, McMahon MT, Kato Y, Liu G, Bulte JW, Bhujwalla ZM, Artemov D, van Zijl PC. Natural D-glucose as a biodegradable MRI contrast agent for detecting cancer. Magn Reson Med. 2012 Dec;68(6):1764-73. doi: 10.1002/mrm.24520. Epub 2012 Oct 16. — View Citation
Nasrallah FA, Pagès G, Kuchel PW, Golay X, Chuang KH. Imaging brain deoxyglucose uptake and metabolism by glucoCEST MRI. J Cereb Blood Flow Metab. 2013 Aug;33(8):1270-8. doi: 10.1038/jcbfm.2013.79. Epub 2013 May 15. — View Citation
Walker-Samuel S, Ramasawmy R, Torrealdea F, Rega M, Rajkumar V, Johnson SP, Richardson S, Gonçalves M, Parkes HG, Arstad E, Thomas DL, Pedley RB, Lythgoe MF, Golay X. In vivo imaging of glucose uptake and metabolism in tumors. Nat Med. 2013 Aug;19(8):1067-72. doi: 10.1038/nm.3252. Epub 2013 Jul 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Integral tumour contrast generated by GBCA and glucose experiments will be assessed using Area Under Curve (AUC). | 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. | 1h procedure | |
Secondary | Maximum instantaneous tumour contrast generated by GBCA and glucose experiments will be assessed. | 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. | 1h procedure |
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