CEST in Low-grade Glioma Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Please see trial details below:

Official Title
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A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma

Conditions
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Low-grade Glioma

Intervention / Treatment
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* Diagnostic Test: Saturation Transfer (ST)-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 12 years of age; Diagnosed with: Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based on any combination of histological, molecular, radiological, and/or clinical findings; or Cohort B (post-surgical): IDH1/2-mutant or IDH-wildtype (WT) low-grade glioma candidate for observation No contraindications to MRI; eGFR > 30 ml/min; No prior chemotherapy or radiation therapy; No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy) Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital Exclusion Criteria: Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy Pregnancy

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ST-MRI scans<br>All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI). | Diagnostic Test: Saturation Transfer (ST)-MRI<br>* Non-contrast magnetic resonance imaging Saturation Transfer scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time-to-progression as measured by Saturation Transfer (ST)-MRI (based on a change in volume or parameter value of over 10%) relative to the time-to-progression as measured by standard MRI using RANO-LGG. | Time-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade. | Up to 6 years, from date of initial (ST)-MRI scan until the date of progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%). | The accuracy will be measured based on Saturation Transfer (ST)-MRI alone without standard MRI. | Up to 6 years, from date of initial (ST)-MRI scan until the date of progression |