ST-MRI for Brain Tumors

Recruiting at 1 trial location

Overseen By Arjun Sahgal, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of MRI scan, called Saturation Transfer (ST)-MRI, to track the progress of low-grade gliomas (LGGs), a type of brain tumor. The goal is to detect early changes in these tumors, allowing for earlier treatment if necessary. This scan could provide more detailed information without contrast injections. Suitable participants have been diagnosed with a low-grade glioma and do not currently require surgery, chemotherapy, or radiation. As an unphased trial, this study offers a unique opportunity to advance non-invasive diagnostic methods for brain tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have had prior chemotherapy or radiation therapy.

What prior data suggests that ST-MRI is safe for evaluating brain tumors?

Research has shown that Saturation Transfer (ST)-MRI is safe in various medical settings. This type of MRI does not require contrast dyes, which other MRI scans often use and can sometimes cause issues.

Studies have also indicated that a similar technique, Chemical Exchange Saturation Transfer (CEST) MRI, is used in many research centers worldwide without major safety concerns. No significant reports have linked this type of MRI to direct problems. It has even tracked safe substances like glucosamine, a common dietary supplement.

In summary, ST-MRI appears well-tolerated and does not cause harmful side effects. This suggests that participating in a trial involving ST-MRI should pose a low safety risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Saturation Transfer MRI (ST-MRI) for brain tumors because it offers a new way to enhance imaging precision. Unlike standard MRI scans, which primarily provide structural images, ST-MRI can measure chemical changes in the brain, potentially offering more detailed insights into tumor metabolism and progression. This technique might help doctors better distinguish between tumor types and assess treatment responses earlier, leading to more personalized and effective patient care.

What evidence suggests that ST-MRI is effective for evaluating low grade gliomas?

Research has shown that Saturation Transfer (ST)-MRI provides valuable information about brain tumors without contrast dye, making it less invasive. In this trial, participants will undergo ST-MRI scans during their standard imaging visits. Studies have found that combining ST-MRI with other imaging methods helps doctors detect tumor changes more effectively. This technique identifies early signs of tumor growth by measuring specific chemical changes in the brain. However, researchers continue to study the overall accuracy of ST-MRI for diagnosis. ^{5 6 7 8 9}

Who Is on the Research Team?

Greg J Stanisz, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 or older with suspected or confirmed low-grade glioma who don't need immediate treatment. They must be able to undergo MRI scans and be followed at specified health centers. Pregnant individuals or those needing post-surgical chemotherapy/radiation are excluded.

Inclusion Criteria

I don't require immediate surgery, chemotherapy, or radiation.

I am diagnosed with a type of brain tumor either before or after surgery, based on specific tests.

No impediments to MRI exist.

Exclusion Criteria

I need chemotherapy or radiation therapy after surgery.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits

Up to 6 years

Follow-up

Participants are monitored for tumour progression using ST-MRI and standard MRI

Up to 6 years

What Are the Treatments Tested in This Trial?

Interventions

• Saturation Transfer (ST)-MRI

Trial Overview

The study tests a non-contrast metabolic 'Saturation Transfer' (ST)-MRI technique on patients with low-grade gliomas to detect early tumor progression, without the use of intravenous contrast agents.

How Is the Trial Designed?

Group I: ST-MRI scans Experimental Treatment 1 Intervention

All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

Endogenous chemical exchange saturation transfer (CEST) MRI shows promise in providing unique diagnostic information for brain tumors, with studies indicating varying accuracy in distinguishing tumor types and grades, but the overall diagnostic accuracy is still not fully established.

Out of 36 studies reviewed, CEST MRI demonstrated high potential in areas like grading gliomas and differentiating recurrence from treatment-related changes, but many studies had a high risk of bias, highlighting the need for further research to validate and standardize this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endogenous Chemical Exchange Saturation Transfer MRI for the Diagnosis and Therapy Response Assessment of Brain Tumors: A Systematic Review. Okuchi, S., Hammam, A., Golay, X., et al.[2023]

A new MRI acquisition protocol for relaxation-compensated amide proton transfer (APT) and relayed nuclear Overhauser effect (rNOE) CEST at 3T has successfully reduced the scanning time from 19 minutes to under 7 minutes, making it more feasible for clinical use.

The new protocol maintains similar contrast behavior and reproducibility compared to the previous method, with limits of agreement below 20%, ensuring reliable results for glioblastoma examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical routine acquisition protocol for 3D relaxation-compensated APT and rNOE CEST-MRI of the human brain at 3T. Goerke, S., Breitling, J., Korzowski, A., et al.[2021]

Chemical Exchange Saturation Transfer (CEST) MRI was successfully implemented in 54 patients with central nervous system tumors during radiotherapy, showing distinct imaging characteristics that differentiate tumor tissue from normal white matter.

The study found that CEST metrics, such as lower MTRAmide and MTRNOE in tumors and higher asymmetry in high-grade tumors, indicate potential for using metabolic imaging to adapt radiotherapy protocols based on tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical exchange saturation transfer MRI in central nervous system tumours on a 1.5 T MR-Linac. Chan, RW., Lawrence, LSP., Oglesby, RT., et al.[2021]

The new variable delay multi-pulse CEST (VDMP-CEST) imaging technique allows for the detection of low concentration proteins and metabolites in MRI without the need for complex Z-spectra analysis, making it simpler and faster.

VDMP-CEST effectively captures slow to intermediate magnetization transfer processes in both model systems and healthy rat brains, demonstrating its potential for improved imaging of biological processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variable delay multi-pulse train for fast chemical exchange saturation transfer and relayed-nuclear overhauser enhancement MRI. Xu, J., Yadav, NN., Bar-Shir, A., et al.[2021]

CEST-MRI can identify early changes in glioblastoma (GBM) characteristics as soon as 2 weeks into standard chemoradiation treatment, helping to distinguish between patients whose tumors are progressing and those whose are not.

Baseline CEST metrics, such as MTRNOE and MTRAmide, can predict tumor progression even before treatment starts, suggesting that these imaging biomarkers could guide personalized treatment plans for GBM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Glioblastoma Response to Therapy With Chemical Exchange Saturation Transfer. Mehrabian, H., Myrehaug, S., Soliman, H., et al.[2019]

The study optimized a CEST imaging protocol for prostate cancer using a 3.0 T MRI, achieving a repeatable saturation scheme that enhances the detection of metabolically derived signals, which could improve cancer diagnosis.

In healthy volunteers, the technique showed good repeatability with low coefficients of variation for amide and NOE signals, indicating its potential reliability for distinguishing between cancerous and non-cancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization and repeatability of multipool chemical exchange saturation transfer MRI of the prostate at 3.0 T. Evans, VS., Torrealdea, F., Rega, M., et al.[2020]

In a study of 21 patients with WHO IV° gliomas, CEST MRI at 7T revealed significant differences in APT and dns-APT signal intensities based on the tumor's hemisphere location, indicating that tumor location can affect imaging results.

The study found a significant inverse correlation between APT/dns-APT and ADC values, suggesting that these imaging techniques may provide complementary information about glioma characteristics, particularly in relation to their anatomical location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical exchange saturation transfer (CEST) signal intensity at 7T MRI of WHO IV° gliomas is dependent on the anatomic location. Dreher, C., Oberhollenzer, J., Meissner, JE., et al.[2022]

CEST MRI is an innovative imaging technique that combines the specificity of magnetic resonance spectroscopy (MRS) with the spatial resolution of MRI, allowing for detailed analysis of tumor metabolism through various methods like GluCEST and CrCEST.

Techniques such as GlucoCEST and AcidoCEST provide insights into glucose transport and extracellular pH in tumors, respectively, highlighting the potential of CEST MRI to enhance our understanding of tumor biology and improve cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessments of tumor metabolism with CEST MRI. Goldenberg, JM., Pagel, MD.[2020]

Chemical exchange saturation transfer (CEST) MRI allows for the detection of low concentrations of metabolites like peptides and glucose without the use of traditional contrast agents or radioactive tracers, making it a safer imaging option.

Clinical studies, particularly in neuro-oncology, indicate that CEST-MRI can provide valuable insights into tumor malignancy and therapeutic responses, potentially improving prognosis assessments and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemical exchange saturation transfer (CEST) : Magnetic resonance imaging in diagnostic oncology]. von Knebel Doeberitz, N., Maksimovic, S., Loi, L., et al.[2022]

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pmc.ncbi.nlm.nih.gov

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In this review, we summarize studies using CEST MRI to image a range of tumor types, including breast cancer, pelvic tumors, digestive tumors, and lung cancer.

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onlinelibrary.wiley.com/doi/full/10.1002/jmri.28440

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translational-medicine.biomedcentral.com

translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-04451-6

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5821273/

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nature.com

nature.com/articles/s41598-023-48515-5

Metabolic brain imaging with glucosamine CEST MRI

The utility of chemical exchange saturation transfer (CEST) MRI for monitoring the uptake of glucosamine (GlcN), a safe dietary supplement, ...

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analyticalsciencejournals.onlinelibrary.wiley.com

analyticalsciencejournals.onlinelibrary.wiley.com/doi/full/10.1002/nbm.4602

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ejnmmiphys.springeropen.com

ejnmmiphys.springeropen.com/articles/10.1186/s40658-016-0155-2

An overview of CEST MRI for non-MR physicists

Chemical exchange saturation transfer (CEST) is a novel MR technique that enables imaging certain compounds at concentrations that are too low ...