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New treatment option for Brain Metastases
Official title Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Patients With Intracranial Metastasis Treated With (SRS)
ClinicalTrials.gov ID: NCT03324360
What this study is testing
What is Hyperpolarized 13C-Pyruvate?
Hyperpolarized 13C-Pyruvate is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for brain metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.