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19F Cell Sense-labeled PBMC for Adverse Drug Reaction (TRACK Trial)
Phase 1
Waitlist Available
Led By Gregory A Dekaban, PhD
Research Sponsored by Gregory A. Dekaban
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 12 months
Awards & highlights
TRACK Trial Summary
This trial is testing if it's safe to use a new way to track cells in the body using MRI, which could help to improve cell-based therapies for cancer and other diseases.
TRACK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse effects as assessed by CTCAE v4.0
Secondary outcome measures
Number of patients with detectable 19F MRI signal at local lymph nodes
Number of patients with detectable 19F MRI signal at the site of injection
TRACK Trial Design
2Treatment groups
Experimental Treatment
Group I: Prostate Cancer PatientsExperimental Treatment2 Interventions
Up to 6 Male prostate cancer patients with metastatic, castration resistant prostate cancer will be enrolled.
19F Cell Sense-labeled PBMC (3 million cells) will be injected intradermally into the upper thigh of each participant above the inguinal lymph node. MRI will be used to image the administration site.
Group II: Healthy VolunteersExperimental Treatment2 Interventions
Up to 6 male or female healthy volunteers will be enrolled.
19F Cell Sense-labeled PBMC (3 million cells) will be injected intradermally into the upper thigh of each participant above the inguinal lymph node. MRI will be used to image the administration site.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
319,234 Total Patients Enrolled
Gregory A. DekabanLead Sponsor
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
9,173 Total Patients Enrolled
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