CEST in Low-grade Glioma Study

Not Applicable

Recruiting

• Conditions: Low-grade Glioma
• Interventions: Diagnostic Test: Saturation Transfer (ST)-MRI

• Registration Number: NCT05996653
• Lead Sponsor: Sunnybrook Health Sciences Centre

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:

Study Timeline

• Study Start: 2022-08-12
• Study First Submitted: 2023-07-06
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Primary Completion: 2028-08-12
• Study Completion: 2028-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ST-MRI scans	Saturation Transfer (ST)-MRI	All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada