Recruiting

Saturation Transfer MRI

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05996653

Conditions

Low-grade Glioma

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Saturation Transfer (ST)-MRI

Study Details

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.

Conditions

Low-grade Glioma

Study ID

NCT05996653

Start date

Aug 12, 2022

Status verified date

Aug, 2023

Completion date

Aug 12, 2028

Anticipated

Primary completion date

Aug 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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).

Interventions

Saturation Transfer (ST)-MRI

Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Mary Jane Lim-Fat, MD

416-480-6100MaryJane.LimFat@sunnybrook.ca

Arjun Sahgal, MD

(416) 480-4998Arjun.Sahgal@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 18, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-08-18.