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

Trial Summary

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 data supports the effectiveness of the treatment ST-MRI for Brain Tumors?

Research shows that Chemical Exchange Saturation Transfer (CEST) MRI, a part of ST-MRI, has been effective in monitoring brain tumor metabolism and response to therapy, particularly in glioblastoma, a type of brain cancer. CEST MRI techniques have been used to track important tumor metabolites and assess treatment response, indicating its potential usefulness in brain tumor management. ^{1 2 3 4 5}

Is ST-MRI safe for use in humans?

The research articles do not provide specific safety data for ST-MRI, but they discuss its use in brain tumor patients and central nervous system tumors, suggesting it is being explored in clinical settings. ^{1 2 5 6 7}

How is the ST-MRI treatment for brain tumors different from other treatments?

ST-MRI, using chemical exchange saturation transfer (CEST), is unique because it provides detailed images of brain tumor metabolism by mapping specific molecules like glutamate and lactate. This technique offers a non-invasive way to assess tumor metabolism and microenvironment, which is not typically available with standard MRI methods. ^{1 2 3 8 9}

What is the purpose of this trial?

Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that typically present in the younger population. This project proposes to use non-contrast metabolic "Saturation Transfer" (ST)-MRI to evaluate LGG tumour progression and aims to predict early changes in LGG. Early identification of LGG patients whose tumours will progress will permit early interventions. ST-MRI does not involve any intravenous injection of contrast and which acquires metabolic information not seen by standard MRI.

Research Team

Greg J Stanisz, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical routine acquisition protocol for 3D relaxation-compensated APT and rNOE CEST-MRI of the human brain at 3T. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Assessments of tumor metabolism with CEST MRI. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Glioblastoma Response to Therapy With Chemical Exchange Saturation Transfer. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Chemical exchange saturation transfer MRI in central nervous system tumours on a 1.5 T MR-Linac. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Variable delay multi-pulse train for fast chemical exchange saturation transfer and relayed-nuclear overhauser enhancement MRI. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Chemical exchange saturation transfer (CEST) : Magnetic resonance imaging in diagnostic oncology]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Optimization and repeatability of multipool chemical exchange saturation transfer MRI of the prostate at 3.0 T. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Endogenous Chemical Exchange Saturation Transfer MRI for the Diagnosis and Therapy Response Assessment of Brain Tumors: A Systematic Review. [2023]