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Hyperpolarized Pyruvate (13C) Injection for Cervical Cancer
Phase 1
Waitlist Available
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 1 year
Awards & highlights
Study Summary
The purpose of this study is to image tumour lactate in study participants with locally advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with diffusion-weighted MRI and 18FDG-PET (fluorodeoxyglucose-positron emission tomography). Furthermore, lactate imaging will potentially provide additional and more specific information regarding the metabolic activity of cervical tumours, thereby identifying regions of radiation resistance and guiding radiation treatment and brachytherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time resolved, 3D 13C lactate images from subjects with cervical cancer.
Secondary outcome measures
Correlation of MRI and 18FDG-PET images
Trial Design
2Treatment groups
Active Control
Group I: Hyperpolarized Pyruvate (13C) InjectionActive Control1 Intervention
Participants will be injected with the study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43 ml/kg and will have their cervix imaged using MRI.
Group II: 18F-FDGActive Control1 Intervention
Participants will be injected with the study drug 18F-FDG at a dose of 5 MBq/kg to a a maximum of 500 MBq (megabecquerel) and will have their cervix imaged using PET-CT imaging.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,304 Total Patients Enrolled
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
9,181 Total Patients Enrolled
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