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Recruiting NCT05996653

CEST in Low-grade Glioma Study

No phase Interventional Low-grade Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saturation Transfer (ST)-MRI.
Who it may be relevant to
Registry conditions: Low-grade Glioma. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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:

Interventions

  • 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)

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%). [Time frame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 2 centers
  • Sunnybrook Health Sciences Centre — Toronto
  • St. Michael's Hospital — Toronto

Identifiers

NCT: NCT05996653 · 5396

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗