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โ† Trials
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Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Patients With Intracranial Metastasis Treated With (SRS)

RecruitingPhase 1Ages 18 Years - anyAllSunnybrook Health Sciences Centre
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In plain words

What the trial is, and whether it could suit you

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 me

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Part I (Controls) Group A * Participants of all ethnic groups/race categories (โ‰ฅ18yrs old) * Informed consent Group B * Male participants of all ethnic groups/race categories (between the age of 18-39) * Informed consent Group C * Female participants of all ethnic groups/race categories (between the age of 18-39) * Informed consent Group D * Male participants of all ethnic groups/race categories (between the age of 40-59) * Informed consent Group E * Female participants of all ethnic groups/race categories (between the age of 40-59) * Informed consent Group F * Male participants of all ethnic groups/race categories (โ‰ฅ60 yrs old) * Informed consent Group G * Female participants of all ethnic groups/race categories (โ‰ฅ60 yrs old) * Informed consent Group H and I * Male or female participants of all ethnic groups/race categories (โ‰ฅ18 yrs old) * Informed consent Group J * Male or female participants of all ethnic groups/race categories (โ‰ฅ60 yrs old) * Informed consent * Diagnosed with mild cognitive impairment Group K * Male or female participants of all ethnic groups/race categories (โ‰ฅ60 yrs old) * Informed consent * Diagnosed with mild Alzheimer's disease Group L * Male or female participants of all ethnic groups/race categories (โ‰ฅ18 years of age) * Informed consent Group M * Male or female participants of all ethnic groups/race categories (โ‰ฅ18 years of age) * Informed consent Part II \& III * Adult participants of all ethnic groups/race categories (age โ‰ฅ18 yrs old) * Radiographic diagnosis of brain metastases and pathological confirmation of a solid cancer primary * Metastatic brain tumor amenable to Stereotactic radiosurgery or radiotherapy * Participants on dexamethasone must be on a stable dose at the time of baseline MRI and 1-5 days post-SRS MRI * Estimated survival more than 6 months * Informed consent Exclusion Criteria: * 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 screening 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. * Pregnant * Claustrophobia to the extent that the participant cannot stay in the MRI for 45-60 minutes * Known adverse reactions to the contrast agent Gd-DTPA * Inability to lie still for 45-60 minutes * 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 * For groups J and K, any other structural brain lesion that could affect cognition
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What it tests

  • Hyperpolarized 13C-Pyruvate
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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