Back to resultsCEST in Low-grade Glioma Study
Primary Purpose
Low-grade Glioma
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Saturation Transfer (ST)-MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Low-grade Glioma
Eligibility Criteria
Inclusion Criteria: Be at least 12 years of age; Diagnosed with: 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; eGFR > 30 ml/min; No prior chemotherapy or radiation therapy; No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy) Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital Exclusion Criteria: Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy Pregnancy
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ST-MRI scans
Arm Description
All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05996653
First Posted
July 6, 2023
Last Updated
August 10, 2023
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT05996653
Brief Title
CEST in Low-grade Glioma Study
Official Title
A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
August 12, 2028 (Anticipated)
Study Completion Date
August 12, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade Glioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ST-MRI scans
Arm Type
Other
Arm Description
All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).
Intervention Type
Diagnostic Test
Intervention Name(s)
Saturation Transfer (ST)-MRI
Intervention Description
Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%).
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 12 years of age;
Diagnosed with:
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;
eGFR > 30 ml/min;
No prior chemotherapy or radiation therapy;
No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy)
Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital
Exclusion Criteria:
Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Jane Lim-Fat, MD
Phone
416-480-6100
Ext
61960
Email
MaryJane.LimFat@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Arjun Sahgal, MD
Phone
(416) 480-4998
Email
Arjun.Sahgal@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg J Stanisz, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Jane MaryJane.LimFat@sunnybrook.ca, MD
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunit Das, MD, PhD
Phone
(416) 864-5548
Email
sunit.das@utoronto.ca
12. IPD Sharing Statement
Learn more about this trial
CEST in Low-grade Glioma Study
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