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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

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