WithdrawnPhase 1

Tracking Peripheral Blood Mononuclear Cells With Fluorine MRI

Stopped: Lack of funding

Canada0Started 2019-07

Plain-language summary

Cell-based therapies in the form of stem cell-based or immune cell-based therapies are becoming important treatment options that are either approved for clinical use or are showing promise in clinical trials. One of the issues regarding cell-based therapies is that, once the cells are injected into a subject, there is no easy way to track where they go, assess whether adequate numbers of cells arrive at the intended therapeutic target and for how long they persist at a given location. To address this issue non-invasive imaging methods have been developed using magnetic resonance imaging (MRI). When used with an appropriate cell labelling contrast agent, Cellular MRI can track cells non-invasively in vivo. Detection of cells is accomplished with an inert imaging agent containing the MRI sensitive fluorine-19 (19F) nuclei. The objective of this study is to demonstrate that 19F-MRI is safe to use in humans so that it can subsequently be used to track cell-based immunotherapies in future clinical trials. The long term goal is to be able to quantify immune cell migration to secondary lymphoid tissues and potentially to tumors and correlate to therapeutic outcomes.

Who can participate

Age range40 Years – 85 Years

SexALL

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Inclusion Criteria: * Men diagnosed with confirmed adenocarcinoma of the prostate * No history of skin hypersensitivities or allergies. * Normal liver functions as defined by alanine aminotransferase (ALT) (3-36 U/L) and aspirate aminotransferase (AST) levels (10-34 U/L) * Normal kidney function by monitoring urea (2.5-8.0 ηmol/L) and creatine (70-120 μmol/L \[for males\]) concentrations. * Normal complete blood count with differential * Body Weight between 40 and 110 kg (relates to being able to fit in scanner) * Body Mass Index \< 30 (relates to being able to fit in scanner) * Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing. Exclusion Criteria: * Contraindication to venipuncture and donation of 100-160 mL of blood * Active infection (not limited to HIV, HTLV1\&2, Hep A, B, C, syphilis) * Participants are on active chemotherapy (not including castrate hormone therapy), radiation therapy or immunosuppressive therapy (i.e. steroid use, anti-transplant rejection drugs, depleting antibodies) * Participants who are unable to have an MRI scan (e.g. history of head or eye injury involving metal fragments, implanted electrical device (such as a cardiac pacemaker), conductive implants or devices such as skin patches, body piercing or tattoos containing metallic inks, severe heart disease (including susceptibility to heart rhythm abnormalities), claustrophobia, etc.) * Participants with known allergies to phenol red, β-lac…

What they're measuring

Number of participants with treatment-related adverse effects as assessed by CTCAE v4.0

Timeframe: 12 months

Trial details

NCT IDNCT02921373

SponsorGregory A. Dekaban

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06