A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low-grade Glioma
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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:
Investigators
Dr. MaryJane Lim Fat
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility 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
Outcomes
Primary Outcomes
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 Frame: 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 Outcomes
- 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)