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Trial Title:
CEST in Low-grade Glioma Study
NCT ID:
NCT05996653
Condition:
Low-grade Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Saturation Transfer (ST)-MRI
Description:
Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of
magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
Arm group label:
ST-MRI scans
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:
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sunnybrook Health Sciences Centre
Address:
City:
Toronto
Zip:
M4N3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Mary Jane MaryJane.LimFat@sunnybrook.ca, MD
Facility:
Name:
St. Michael's Hospital
Address:
City:
Toronto
Zip:
M5B 1W8
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Sunit Das, MD, PhD
Phone:
(416) 864-5548
Email:
sunit.das@utoronto.ca
Start date:
August 12, 2022
Completion date:
August 12, 2028
Lead sponsor:
Agency:
Sunnybrook Health Sciences Centre
Agency class:
Other
Source:
Sunnybrook Health Sciences Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996653