MRI Techniques with Alcohol Challenge for Neuroimaging

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Metronidazole

Disqualifiers: MRI contraindications, Alcohol abuse, Liver pathology

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure brain fluid flow using MRI techniques and alcohol ingestion as a marker. The goal is to determine if this approach can detect brain waste clearance issues linked to neurodegenerative diseases. Healthy volunteers who consume fewer than six alcoholic drinks per week will help test this method. Various MRI techniques will identify which works best for measuring this flow. If successful, this method could diagnose and monitor brain conditions in the future. As an unphased study, this trial offers volunteers a unique opportunity to contribute to groundbreaking research that may lead to new diagnostic tools for brain health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications like metronidazole that could cause a reaction with alcohol.

What prior data suggests that this MRI technique is safe for neuroimaging?

Research shows that the treatments in this trial are generally safe and well-tolerated. Here's a simpler breakdown:

1. **Single-voxel MRS**: Studies indicate that Magnetic Resonance Spectroscopy (MRS) is safe because it doesn't use injected dyes or harmful radiation. It's commonly used to study brain health due to its straightforward nature and clear results.

2. **Multi-voxel MRSI**: Similar to single-voxel MRS, this method can take longer to set up and might not always be as clear. However, it also avoids harmful substances, which is important for safety.

3. **Magnetization Transfer Imaging (MTI)**: Research suggests that MTI is safe and effective for detecting changes in the brain. It doesn't use harmful radiation, making it a safe imaging option.

Overall, these imaging techniques are non-invasive and avoid harmful substances, supporting their safety for humans. Existing research reassures participants about the safety of these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new MRI techniques in combination with alcohol challenges to better understand brain function and metabolism. Unlike standard imaging methods, this trial uses advanced techniques like Magnetization Transfer Imaging and Multi-voxel MRSI, which may provide more detailed insights into the brain's response to alcohol. These innovative imaging methods, paired with tools like ClearMate for controlled oxygen delivery, aim to uncover more nuanced data about brain chemistry changes. This could lead to new ways to study and potentially treat conditions influenced by alcohol.

What evidence suggests that this trial's techniques could be effective for measuring intracranial interstitial fluid flow?

Research has shown that Single-voxel Magnetic Resonance Spectroscopy (MRS), one of the techniques studied in this trial, provides detailed information about brain chemicals from specific areas. Studies have found it useful for assessing brain tumors and other neurological conditions. Multi-voxel Magnetic Resonance Spectroscopic Imaging (MRSI), another technique under investigation, offers a broader view by capturing data from multiple brain areas simultaneously, helping to identify changes in brain chemistry related to diseases. Magnetization Transfer Imaging (MTI), also evaluated in this trial, effectively detects changes in brain tissue, which is important for conditions like multiple sclerosis. Each of these imaging techniques has demonstrated potential in revealing significant brain changes, aiding diagnosis, and monitoring treatment effects for various brain disorders. ^{1 5 6 7 8}

Who Is on the Research Team?

Greg J Stanisz, PhD

Principal Investigator

Sunnybrook Research Institute

David Mikulis, MD

Principal Investigator

Krembil Research Institute

Are You a Good Fit for This Trial?

This trial is for healthy male volunteers aged 20-75 who drink less than 6 alcoholic beverages per week. Participants must be able to consent, communicate with the researcher, and follow study procedures. They can't join if they have a history of alcohol or substance abuse, liver problems, are taking certain medications like metronidazole, or cannot undergo an MRI.

Inclusion Criteria

Low consumer of ethanol (less than 6 drinks per week where a drink is 1 oz of distilled spirits, 6 oz wine, 12 oz beer)

I can understand and agree to the study's requirements.

Exclusion Criteria

You have a history of excessive alcohol or drug use.

I am on medication that reacts badly with alcohol.

I have a history of liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-Experiment Preparation

Participants fast for 6 hours and refrain from alcohol for 12 hours before the experiment

1 day

Experiment

Participants undergo MR acquisition, consume ethanol, and have repeated MR scans for 60-90 minutes

1 day

1 visit (in-person)

Post-Experiment Monitoring

Participants are monitored until blood ethanol levels are below 0.05% and feel safe to leave

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects and data analysis is performed

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol ingestion
• Blood sampling
• ClearMate
• Magnetization Transfer Imaging
• Multi-voxel MRSI
• Single-voxel MRS

Trial Overview The study is testing a new non-invasive method using magnetic resonance spectroscopy (MRS) and ethanol as a marker to measure fluid flow in the brain. The goal is to develop this technique in healthy individuals first before applying it to patients with neurological disorders.

How Is the Trial Designed?

Group I: Single-voxel MRS + ClearMate + Blood Sampling Active Control 4 Interventions

MRS+CM+B

Group II: Multi-voxel MRSI + ClearMate + Blood Sampling Active Control 4 Interventions

MRSI+CM+B

Group III: Magnetization Transfer Imaging + ClearMate + Blood Sampling Active Control 4 Interventions

MTI+CM+B

Group IV: Multi-voxel MRSI + ClearMate Active Control 3 Interventions

MRSI+CM

Group V: Magnetization Transfer Imaging + ClearMate Active Control 3 Interventions

MTI+CM

Group VI: Single-voxel MRS + ClearMate Active Control 3 Interventions

MRS+CM

Group VII: Single-voxel MRS Active Control 2 Interventions

MRS

Group VIII: Magnetization Transfer Imaging Active Control 2 Interventions

MTI

Group IX: Multi-voxel MRSI Active Control 2 Interventions

MRSI

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Citations

1. nature.com nature.com/articles/s41398-022-01939-5

Magnetization transfer imaging alterations and its ... This study aims to identify brain magnetization transfer ratio (MTR) changes in antipsychotic-naïve first-episode schizophrenia (FES), and to correlate MTR ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S187874792300630X

Magnetization Transfer Magnetic Resonance Imaging of ... Magnetization transfer MRI (MT-MRI) has been one of the most extensively applied for the assessment of CNS disorders.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7479733/

Magnetization transfer magnetic resonance imaging of the ... Magnetization transfer imaging and proton MR spectroscopy in the evaluation of axonal injury: correlation with clinical outcome after traumatic brain injury.

4. academic.oup.com academic.oup.com/braincomms/article/4/2/fcac088/6563393

Quantitative magnetization transfer imaging in relapsing ... Evidence suggests that magnetization transfer imaging metrics are sensitive to pathological brain changes in relapsing-remitting multiple sclerosis.

5. dirjournal.org dirjournal.org/pdf/beb8919b-f013-4ea1-b1c8-40332e840fe1/articles/56234/Diagn%20Interv%20Radiol-11-137-En.pdf

The effectiveness of magnetization transfer technique in the ... The purpose of this study was to determine the value of MT imaging in the evaluation of acute plaques, which cause clinical findings in the brain MR images of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078817409000625

A review of the safety implications of magnetic resonance ... This review aims to identify the clinical safety implications in performing MRI at field strengths of 3 Tesla (T) and above and determine whether the current ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2873052/

Magnetization transfer imaging, white matter hyperintensities ... MTR in older adults may be an important additional marker of brain abnormalities associated with slower gait.

8. mriquestions.com mriquestions.com/mt-imagingcontrast.html

Magnetization Transfer Imaging Magnetization transfer imaging (MTI) is a technique by which radiofrequency (RF) energy is applied exclusively to the bound pool using specially designed MT ...