CEST in Low-grade Glioma Study

August 10, 2023 updated by: Dr. MaryJane Lim Fat, Sunnybrook Health Sciences Centre

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

Intervention / Treatment

Detailed Description

Please see trial details below:

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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