Comparing 3 approaches for brain metastases
Official title: Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Patients With Intracranial Metastasis Treated With (SRS)
The Feasibility and Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Monitoring Patients With Intracranial Metastasis Treated With Stereotactic Radiosurgery (SRS)
- Phase 1
- 3 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
Hyperpolarized 13C-Pyruvate
MRI with Hyperpolarized 13C-Pyruvate Injection
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for49 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male participants of all ethnic groups/race categories (between the age of 18-39)
- +Female participants of all ethnic groups/race categories (between the age of 18-39)
- +Male participants of all ethnic groups/race categories (between the age of 40-59)
- +Female participants of all ethnic groups/race categories (between the age of 40-59)
- +Adult participants of all ethnic groups/race categories (age ≥18 yrs old)
- +Participants on dexamethasone must be on a stable dose at the time of baselineBaselineYour starting measurements, taken before treatment begins.Read more → MRI and 1-5 days post-SRS MRI
- +Radiographic diagnosis of brain metastases and pathological confirmation of a solid cancer primary
- +Part I (ControlsControl groupThe group a new treatment is measured against.Read more →) Group A
- +Participants of all ethnic groups/race categories (≥18yrs old)
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → Group B
- +Informed consent Group C
- +Informed consent Group D
- +Informed consent Group E
- +Informed consent Group F
- +Male participants of all ethnic groups/race categories (≥60 yrs old)
- +Informed consent Group G
- +Female participants of all ethnic groups/race categories (≥60 yrs old)
- +Informed consent Group H and I
- +Male or female participants of all ethnic groups/race categories (≥18 yrs old)
- +Informed consent Group J
- +Male or female participants of all ethnic groups/race categories (≥60 yrs old)
- +Informed consent
- +Diagnosed with mild cognitive impairment Group K
- +Male or female participants of all ethnic groups/race categories (≥60 yrs old)
- +Informed consent
- +Diagnosed with mild Alzheimer's disease Group L
- +Male or female participants of all ethnic groups/race categories (≥18 years of age)
- +Informed consent Group M
- +Male or female participants of all ethnic groups/race categories (≥18 years of age)
- +Informed consent
- +Part II \& III
- +Estimated survival more than 6 months
- +Informed consent
- +Metastatic brain tumor amenable to Stereotactic radiosurgery or radiotherapy
Exclusion
- −Claustrophobia to the extent that the participant cannot stay in the MRI for 45-60 minutes
- −Inability to lie still for 45-60 minutes
- −For groups J and K, any other structural brain lesion that could affect cognition
- −Prior brain radiotherapy for the specific index or lesion to be imaged in the study
- −For groups B to I, L, and M only: Montreal Cognitive Assessment (MoCA) score \<26
- −The participant will also be asked to complete the standard MRI safety screeningScreeningThe checks done before joining, to see whether a study fits.Read more → questionnaire, prior to their research scan and participation in the study.
- −Contraindications to MRI including:
- −Participants weighing \>136 kg (weight limit for the scanner tables)
- −Participants with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
- −Known adverse reactions to the contrast agent Gd-DTPA
- −Participants with a high risk factor for nephrogenic systemic fibrosis (NFS).
- −Participant declines the procedure or further procedures;
- −Participant is not well enough to undergo MRI scanning;
- −Participant is unable to complete the MRI procedure for any reason or is non-compliant with MRI requirements.
- −For groups J and K, a \<1 lacunar infarct or any cortical subcortical infarct or moderate to severe white matter disease
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A, B and C receive Hyperpolarized 13C-Pyruvate.
Registry label: A: Control Participants Part I · B: Intracranial Metastasis Part II · C: Intracranial Metastasis Part III
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 276 people.
The study is currently expected to finish around January 2027.
The main measurement is taken over: ~30-60 minutes of MRI time.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Is an MRI image produced? Y/N? — measured over ~30-60 minutes of MRI time.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03324360 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Hyperpolarized 13C-PyruvateDrug
MRI with Hyperpolarized 13C-Pyruvate Injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: ~30-60 minutes of MRI time..
The study as a whole is currently expected to finish around 2027-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 276 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Upwards of 40% of cancer patients will develop brain metastases during their illness, most of which become symptomatic. The burden of brain metastases impacts the quality and length of survival. Thus the management of brain metastases is a significant health care problem. Standard treatment options include stereotactic radiosurgery and/or whole brain radiation. There is a great interest in studying the association between the functional characteristics of tumors - such as tumour hypoxia and lactate accumulation - and clinical outcomes in order to guide management. These characteristics may predict future tumor behavior and stratify risk of therapy failure. Hyperpolarized 13C MR imaging is a novel functional imaging technique that uses 13C-labeled molecules, such as pyruvate, and MRS to image in vivo tissue metabolism. There is significant clinical heterogeneity in patients with brain metastasis due to differences in underlying tumour biology. Biochemical differences in tumour metabolism have been shown to correlate with response to therapy. While the significance of tissue hypoxia for radiosensitivity has been established for years, the impact of lactate accumulation on radiosensitivity has only recently been recognized. Studies have shown that tissue lactate levels correlate with radioresistance in several human tumours. Hyperpolarized 13C pyruvate MRS has been shown in numerous pre-clinical studies and a recent clinical study to have great potential as a metabolic imaging tool. Our study seeks to establish the role of hyperpolarized 13C MRS in characterizing the metabolic features of intracranial metastasis. The results of this study will provide insight into intracranial metastatic disease signatures with MR spectroscopy and determine if there is added benefit for incorporation of this new technique into future clinical MRI protocols. If the technique can accurately differentiate between aggressive and indolent tumours based on MR spectroscopic patterns, hyperpolarized 13C MRS may have wide-ranging utility in the future. In the era of personalized medicine, the ability of imaging tests to predict response to therapy would open the door for individualized treatment options specific to each patient's disease biology.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.