CEST in Low-grade Glioma Study

Sunnybrook Health Sciences Centre100 enrolled

Overview

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.

Please see trial details below:

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Low-grade Glioma

Interventions

Saturation Transfer (ST)-MRIDIAGNOSTIC_TEST

Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

NOT_YET_RECRUITING

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-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade.

Time frame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression

Secondary Outcomes

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.

Time frame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression

Central Contacts

Mary Jane Lim-Fat, MD

CONTACT

416-480-6100 MaryJane.LimFat@sunnybrook.ca

Arjun Sahgal, MD

CONTACT

(416) 480-4998 Arjun.Sahgal@sunnybrook.ca

Data from ClinicalTrials.gov

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