Low-grade Glioma
Conditions
Brief summary
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
Please see trial details below:
Interventions
DIAGNOSTIC_TESTSaturation Transfer (ST)-MRI
Non-contrast magnetic resonance imaging Saturation Transfer scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be at least 12 years of age; 2. Diagnosed with: 1. Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based on any combination of histological, molecular, radiological, and/or clinical findings; or 2. Cohort B (post-surgical): IDH1/2-mutant or IDH-wildtype (WT) low-grade glioma candidate for observation 3. No contraindications to MRI; 4. eGFR \> 30 ml/min; 5. No prior chemotherapy or radiation therapy; 6. No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy) 7. Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital
Exclusion criteria
1. Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy 2. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Up to 6 years, from date of initial (ST)-MRI scan until the date of progression | Time-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%). | Up to 6 years, from date of initial (ST)-MRI scan until the date of progression | The accuracy will be measured based on Saturation Transfer (ST)-MRI alone without standard MRI. |
Countries
Canada
Contacts
Primary ContactMary Jane Lim-Fat, MD
Backup ContactArjun Sahgal, MD
Outcome results
None listed