Tracking Peripheral Blood Mononuclear Cells With Fluorine MRI

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.

Conditions

• Adverse Reaction to Diagnostic Agents and Kits Nos

Interventions

BIOLOGICAL

19F Cell Sense-labeled PBMC

Peripheral blood mononuclear cells (PBMC) will be isolated from patient whole blood samples and labeled in a GMP facility with GMP grade 19F Cell Sense imaging agent. These cells will be re-administered to the patient prior to imaging.

DEVICE

MRI

Participants will undergo Magnetic Resonance Imaging (MRI) at 1 hour and 24 hours following PBMC administration

Sponsors & Collaborators

• Western University, Canada

  collaborator OTHER

• Ontario Institute for Cancer Research

  collaborator OTHER

• Gregory A. Dekaban

  lead OTHER

Principal Investigators

• Gregory A Dekaban, PhD · Robarts Research Institte - Western Universtiy

• Paula J Foster, PhD · Robarts Research Institte - Western Universtiy

• Sowmya Vuswanathan, PhD · University Health Network - University of Toronto

• Joseph Chin, MD · London Health Research Institute - Western University

• Michael Rieder, MD PhD · Robarts Research Institte - Western University

• Gary Brahm, MD · London Health Research Institute

• Doreen Matsui, MD · Western University

• George Dresser, MD · Western University

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-31

Primary Completion

2022-06-30

Completion

2022-12-31

FDA Drug

Yes

Countries

• Canada

Study Locations