CEST in Low-grade Glioma Study

Low-grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996653
• Other study ID #: 5396
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: August 12, 2028

Study information

• Verified date: August 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Mary Jane Lim-Fat, MD
• Phone: 416-480-6100
• Email: MaryJane.LimFat[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see trial details below:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 12, 2028
• Est. primary completion date: August 12, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Low-grade Glioma

Intervention

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)

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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