Using advanced MRI to study brain metastases in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the use of hyperpolarized 13C MR spectroscopy to assess the metabolic characteristics of brain metastases in patients undergoing stereotactic radiosurgery. Participants will include those with intracranial metastases as well as control participants with mild cognitive impairment and Alzheimer's disease. The study aims to explore the relationship between tumor metabolism and clinical outcomes, potentially guiding future treatment strategies. Participants will undergo MRI scans with hyperpolarized 13C pyruvate injections to evaluate in vivo tissue metabolism.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Part I (Controls) Group A

* Participants of all ethnic groups/race categories (≥18yrs 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 (≥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

* Adult participants of all ethnic groups/race categories (age ≥18 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

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Charles Cunningham, PhD — Sunnybrook Research Institute
• Study coordinator: Norberto Garcia
• Email: norberto.garcia@sunnybrook.ca
• Phone: 416.480.6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.