CEST in Low-grade Glioma Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Please see trial details below:
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: ST-MRI scans 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
Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N3M5 |
| 2 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
- Principal Investigator: Greg J Stanisz, PhD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5396