CEST in Low-grade Glioma Study

A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma

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.

Study Overview

• Status: Recruiting
• Conditions: Low-grade Glioma
• Intervention / Treatment: Diagnostic test: Saturation Transfer (ST)-MRI

Detailed Description

Please see trial details below:

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Jane Lim-Fat, MD; Phone Number: 61960 416-480-6100; Email: MaryJane.LimFat@sunnybrook.ca
• Study Contact Backup: Name: Arjun Sahgal, MD; Phone Number: (416) 480-4998; Email: Arjun.Sahgal@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Mary Jane MaryJane.LimFat@sunnybrook.ca, MD
    • Toronto, Ontario, Canada, M5B 1W8
      • Not yet recruiting
      • St. Michael's Hospital
      • Contact: Sunit Das, MD, PhD; Phone Number: (416) 864-5548; Email: sunit.das@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 years, from date of initial (ST)-MRI scan until the date of progression

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 years, from date of initial (ST)-MRI scan until the date of progression

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Greg J Stanisz, PhD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Estimated): August 12, 2028
• Study Completion (Estimated): August 12, 2028

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 5396

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No