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NCT Number: NCT05996653

CEST in Low-grade Glioma Study

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.

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Key information

Conditions

Low-grade Glioma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

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About this study

Please see trial details below:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

    Time-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade.

Secondary outcomes

  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

    The accuracy will be measured based on Saturation Transfer (ST)-MRI alone without standard MRI.

Study contacts

Contact information is provided by the study sponsor or research team.

Arjun Sahgal, MD

CONTACT

[email protected]

(416) 480-4998

Mary Jane Lim-Fat, MD

CONTACT

[email protected]

416-480-6100 ext. 61960

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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