CEST in Low-grade Glioma Study
ConditionLow-grade Glioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be at least 12 years of age;
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;
Disqualifiers
Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Saturation Transfer (ST)-MRI
Diagnostic testNon-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ST-MRI scansOther 1 intervention
Trial outcomes
Primary outcomes
1
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 progressionSecondary outcomes
1
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 progressionSponsors and contacts
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Source ClinicalTrials.gov