Clinical trial · Interventional
CEST- Glucose Enhanced MRI for Metastatic Brain Tumours
Detection of Metastatic Brain Tumours Using Dynamic Glucose Enhanced MRI After D-glucose Injection
NCT02796729CI-TRIAL-00036785terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms, Malignant | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Metastasis | Brain Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50% dextrose solution | Drug | — | UNRESOLVED |
| Gadovist (Gadobutrol) | Drug | — | UNRESOLVED |
| Magnetic resonance imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dynamic glucose enhanced MRI after D-glucose injection
- description
- 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.
- interventionNames
- Procedure: Magnetic resonance imaging
- Drug: Gadovist (Gadobutrol)
- Drug: 50% dextrose solution
Primary outcomes (1)
- measure
- Integral tumour contrast generated by GBCA and glucose experiments will be assessed using Area Under Curve (AUC).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDChan 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. PMID 23074027
- BACKGROUNDNasrallah FA, Pages 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. PMID 23673434
- BACKGROUNDWalker-Samuel S, Ramasawmy R, Torrealdea F, Rega M, Rajkumar V, Johnson SP, Richardson S, Goncalves 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. PMID 23832090