CEST in Low-grade Glioma Study

NCT05996653 | Recruiting

• 1 other identifier: 5396
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%).

  Up to 6 years, from date of initial (ST)-MRI scan until the date of progression

Study Arms (1)

ST-MRI scans

OTHER

All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).

Diagnostic Test: Saturation Transfer (ST)-MRI

Interventions

Saturation Transfer (ST)-MRI DIAGNOSTIC_TEST

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

ST-MRI scans

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
• Pregnancy

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Study Officials

• Greg J Stanisz, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Jane Lim-Fat, MD

CONTACT

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

Arjun Sahgal, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 18, 2023
• Study Start: August 12, 2022
• Primary Completion (Estimated): August 12, 2028
• Study Completion (Estimated): August 12, 2028
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

CA (2)