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Hyperpolarized Pyruvate Imaging for Brain Tumors
Phase 1
Recruiting
Led By Charles Cunningham, PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~30-60 minutes of mri time.
Awards & highlights
Study Summary
This trial is studying a new way to image brain tumors to see if it can help doctors better understand how to treat them.
Who is the study for?
Adults of any ethnicity with brain metastases from solid cancers, at least one tumor over 1 cm suitable for radiosurgery or radiotherapy, on a stable steroid dose, expected to live more than 6 months. Excludes those with prior brain radiotherapy for the lesion in question, certain cognitive impairments, MRI contraindications like pacemakers or severe claustrophobia, known reactions to contrast agents used in MRIs, and inability to lie still.Check my eligibility
What is being tested?
The trial is testing Hyperpolarized 13C-Pyruvate using MR Spectroscopy to see if it can help characterize metabolic features of brain tumors and predict their behavior. This could lead to personalized treatment plans based on individual tumor biology.See study design
What are the potential side effects?
While specific side effects are not listed for this imaging technique, typical MRI-related side effects may include discomfort from lying still during the procedure and potential allergic reactions to contrast agents.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ~30-60 minutes of mri time.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~30-60 minutes of mri time.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Is an MRI image produced? Y/N?
Trial Design
3Treatment groups
Experimental Treatment
Group I: Intracranial Metastasis Part IIIExperimental Treatment1 Intervention
MRI with injection of hyperpolarized 13C pyruvate prior to radiation treatment. MRI with injection of hyperpolarized 13C pyruvate1-5 days following radiation treatment.
Group II: Intracranial Metastasis Part IIExperimental Treatment1 Intervention
MRI with injection of hyperpolarized 13C pyruvate prior to radiation treatment.
Group III: Control Participants Part IExperimental Treatment1 Intervention
A MRI with injection of hyperpolarized 13C pyruvate.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,152 Total Patients Enrolled
Charles Cunningham, PhDPrincipal InvestigatorSunnybrook Research Institute
5 Previous Clinical Trials
115 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man over 60 and willing to give informed consent.You cannot have an MRI if you weigh more than 136 kg, have a pacemaker, cerebral aneurysm clips, shrapnel injury, or certain implantable electronic devices. Pregnant participants, those with severe claustrophobia, known allergic reactions to contrast agent, or high risk for nephrogenic systemic fibrosis are also excluded. Additionally, participants who are unable to lie still, undergo the procedure, or comply with MRI requirements are not eligible.I am 60 years or older and have given my informed consent.I am an adult with brain metastases from solid cancer, eligible for specific brain tumor treatment, and expected to live more than 6 months.For groups J and K: You have had a specific type of stroke or have significant white matter disease.I have a brain condition that could impact my thinking or memory.If you are in groups B to I, you will be excluded if your Montreal Cognitive Assessment (MoCA) score is less than 26.I am 18 or older and have given my informed consent.I am a woman aged 18-39 and agree to participate.I am 60 or older with a diagnosis of mild Alzheimer's disease and can give informed consent.I am a man aged 18-39 and agree to participate.I have had brain radiotherapy for the lesion being studied.I am over 18 and have agreed to participate in this study.I am a woman aged 40-59 and have agreed to participate.I am a woman over 60 and willing to give informed consent.I am a man aged 40-59 and agree to participate.I am 60 or older with a diagnosis of mild cognitive impairment and can give informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: Control Participants Part I
- Group 2: Intracranial Metastasis Part II
- Group 3: Intracranial Metastasis Part III
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for participants in this clinical experiment?
"Affirmative. Clinicaltrials.gov details confirm that this medical research, initially listed on December 6th 2017, is currently enrolling participants. 156 people need to be sourced from 1 trial site."
Answered by AI
What is the cap on participants in this clinical trial?
"Yes, this medical trial is in progress. According to the clinicaltrials.gov database, it was first posted on December 6th 2017 and recently updated on May 4th 2022. 156 patients will be recruited from a single location for participation."
Answered by AI
What health risks have been observed in individuals taking Hyperpolarized 13C-Pyruvate?
"Taking into consideration the limited data concerning efficacy and safety, Hyperpolarized 13C-Pyruvate was assigned a rating of 1."
Answered by AI
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