Using advanced MRI to study brain metastases in cancer patients
The Feasibility and Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Monitoring Patients With Intracranial Metastasis Treated With Stereotactic Radiosurgery (SRS)
This study is testing a special MRI technique to see how brain tumors in cancer patients use energy and how that might affect their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03324360 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with evidence of intracranial metastases who are scheduled for radiation therapy.
Not a fit: Patients with conditions unrelated to brain metastases or those not eligible for MRI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of tumor behavior and improve treatment strategies for patients with brain metastases.
How similar studies have performed: While the use of hyperpolarized 13C MR spectroscopy is a novel approach, similar imaging techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.