Low-grade GliomaNCT05996653
CEST in Low-grade Glioma Study
A study testing Saturation Transfer (ST)-MRI in people with Low-grade Glioma, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Low-grade Glioma
- What is being tested?
- Saturation Transfer (ST)-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 12 Aug 2022to 12 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Mary Jane MaryJane.LimFat@sunnybrook.ca, MD
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Sunit Das, MD, PhD, (416) 864-5548, sunit.das@utoronto.ca
About this study
Official title: A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma
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.
Read the detailed description
Please see trial details below:
- Conditions
- Low-grade Glioma
- Being tested
- Saturation Transfer (ST)-MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saturation Transfer (ST)-MRIDiagnostic test
Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Saturation Transfer (ST)-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%).
The accuracy will be measured based on Saturation Transfer (ST)-MRI alone without standard MRI.
Measured: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start12 Aug 2022
- Primary completion12 Aug 2028 (estimated)
- Study completion12 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. MaryJane Lim Fat, Sunnybrook Health Sciences Centre
- Investigators
- Greg J Stanisz, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996653
- Sponsor's protocol ID
- 5396
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma
- ClinicalTrials.gov ID
- NCT05996653
- Acronym / sponsor ID
- 5396
- Conditions
- Low-grade Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 12 Aug 2028 (estimated)
- Study completion
- 12 Aug 2028 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST-MRI scans | Other | Diagnostic Test: Saturation Transfer (ST)-MRIAll patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Be at least 12 years of age;
- Diagnosed with:
- No contraindications to MRI;
- eGFR > 30 ml/min;
- No prior chemotherapy or radiation therapy;
Key exclusion criteria (2 listed)
- Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saturation Transfer (ST)-MRINon-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) | Diagnostic test | ST-MRI scans |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Greg J Stanisz, PhD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saturation Transfer (ST)-MRI in people with Low-grade Glioma, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Jane Lim-Fat, MD (416-480-6100 ext. 61960, MaryJane.LimFat@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.