Status:
RECRUITING
Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Patients With Intracranial Metastasis Treated With (SRS)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This is a pilot prospective, single-institution study in both control participants, control participants with mild cognitive impairment and Alzheimer's disease and participants with evidence of intrac...
Eligibility Criteria
Inclusion
- 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
- 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
- At least 1 intracranial metastasis ≥1 cm in size
- Metastatic brain tumour amenable to Stereotactic radiosurgery or radiotherapy
- Participants on stable dexamethasone dose at the time of baseline MRI and 1-5 days post-SRS MRI
- Estimated survival more than 6 months
- Informed consent
Exclusion
- Prior brain radiotherapy for the specific index or lesion to be imaged in the study
- For groups B to I 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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03324360
Start Date
December 6 2017
End Date
January 1 2025
Last Update
April 22 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5