Tracking Peripheral Blood Mononuclear Cells With Fluorine MRI

NCT02921373 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: CS-PBMC-2015-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

perfluorocarbon imaging; peripheral blood mononuclear cells; cancer immunotherapy; prostate cancer; MRI

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (2)

• Number of patients with detectable 19F MRI signal at the site of injection

  1hr post injection

• Number of patients with detectable 19F MRI signal at local lymph nodes

  24 hours post injection

Study Arms (2)

Prostate Cancer Patients

EXPERIMENTAL

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.

Biological: 19F Cell Sense-labeled PBMC; Device: MRI

Healthy Volunteers

EXPERIMENTAL

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.

Biological: 19F Cell Sense-labeled PBMC; Device: MRI

Interventions

19F Cell Sense-labeled PBMC BIOLOGICAL

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.

Healthy Volunteers; Prostate Cancer Patients

MRI DEVICE

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

Healthy Volunteers; Prostate Cancer Patients

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-lactams and β-lactam derivative
• Participants with known allergies to streptomycin sulfate and gentamicin sulfate
• Participants with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. participants who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator.

Sponsors & Collaborators

• Gregory A. Dekaban: lead
• Western University, Canada: collaborator
• Ontario Institute for Cancer Research: collaborator

Study Sites (1)

Robarts Research Institute

London, Ontario, N6A 5B7, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gregory A Dekaban, PhD

  Robarts Research Institte - Western Universtiy

  PRINCIPAL INVESTIGATOR

• Paula J Foster, PhD

  Robarts Research Institte - Western Universtiy

  PRINCIPAL INVESTIGATOR

• Sowmya Vuswanathan, PhD

  University Health Network - University of Toronto

  PRINCIPAL INVESTIGATOR

• Joseph Chin, MD

  London Health Research Institute - Western University

  STUDY CHAIR

• Michael Rieder, MD PhD

  Robarts Research Institte - Western University

  STUDY CHAIR

• Gary Brahm, MD

  London Health Research Institute

  STUDY CHAIR

• Doreen Matsui, MD

  Western University

  STUDY CHAIR

• George Dresser, MD

  Western University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 3, 2016
• Study Start: July 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)